Business

7 Common Mistakes to Avoid When Submitting a 510K to the FDA

Published

4 years ago

January 21, 2022

The FDA deserves credit for ensuring high patient safety standards. However, there is no ignoring the hassle medical device manufacturers go through when submitting 510K applications. They spend hours collecting documents and data from multiple departments only to face a 36% prospect of having their application rejected.

While there is no formula to always getting your submissions cleared by the FDA, you can increase your chances of approval and avoid delivery delays and unnecessary stoppages by ironing out things on your end. Here are some of the most common mistakes manufacturers make that you can easily avoid:

1. Losing track of your product’s regulatory history

Your company ought to know its product’s regulatory history in the U.S., since that’s what 510Ks are based on. Unfortunately for most companies, poor data-keeping leads to loss of important information resulting in a bitter clash with the FDA. No matter the history of your product, it’s good to keep data where you can access it and not likely to lose it. A dedicated clinical metadata repository software tool, such as Formedix Ryze can help you take control of the key challenges associated with keeping and organizing data.

2. Using incorrect FDA templates

Up in the FDA checklist is the correct use of their templates. The agency requires that each section of all 510K submissions be based on an FDA-issued template. Most manufacturers remember this but then forget how rapidly the FDA updates these templates. While using an older template doesn’t automatically render your submission void, it increases your chances of leaving out some data, which you can’t get away with. For this reason, it’s good to confirm that the template on your hands is the latest issued by the FDA before drafting your application.

3. Data irregularity

The FDA requires that you be consistent with the information you provide if it appears multiple times in your application. If there is a discrepancy in your wording, your application will likely be flagged and even rejected. So while keeping your intent consistent, make a point of doing the same with your wording for the sake of your application’s approval.

4. Skipping sections

A typical 510K application form has 20 sections, some of which may not apply to your device. For most manufacturers, irrelevant sections include Electromagnetic Compatibility and Electrical Safety, Performance Testing and Proposed Labeling, Disclosure Statement or Financial Certification, and Class 3 Summary and Certification. If any of the sections don’t apply to you, it is required that you confirm it in writing.

5. Choosing an incorrect predicate (comparison) device

The FDA will treat your device like they did a previously cleared one, meaning you have to identify a device whose parameters match those of yours. Your predicate of choice should bear similarity in design, size, materials, packaging, indications for use, and other considerations, failure to which you will draw out the review process, and even risk rejection. For instance, if your device requires sterilization before use, while the predicate is supplied sterilized, the FDA will ask for more information before getting on with the review process.

6. Failing to comply with the Refusal to Accept provisions

Nearly 90 percent of all rejected submissions are tossed out before being reviewed by a human. This is because they don’t tick off the Refusal To Accept (RTA) checklist, which outlines across-the-board prerequisites. Meeting the RTA requirements simply means your device is worthy of an FDA review and has a realistic chance of being cleared.

7. Misunderstanding the point of a 510K submission

The 510 (k) has evolved quite remarkably over the years. Some time back, it was an endless series of paperwork submissions; now, it’s a streamlined affair that makes maximum use of mainstream contemporary technology. In all that, one thing remains the same: the purpose of the 510K, which is clearance through association or clearance for devices similar to other previously cleared devices.

Failure to understand that can have you wondering why the FDA is hard on you. As stated above, you should have a predicate device at the ready or even model your device on an existing one. That is not to say you should shy from being creative. However, if you want it easy with the FDA, you have to make it easy for them first.

Endnote

If you have been struggling to meet the requirements for a 510K clearance, you’re in good company. The process requires time, manpower, data, and a ton of resilience. It doesn’t have to be a hassle, though. By avoiding the above mistakes, you can massively simplify the process and speed up the review process.

Business

Inside the $4.3B Quarter: What’s Fueling Black Banx’s Record Revenues

Published

12 hours ago

January 16, 2026

Matthew Wiles

Every quarter brings fresh headlines in fintech, but few make the kind of impact achieved by Black Banx in Q2 2025. The Toronto-based global digital banking group, founded by Michael Gastauer, reported an extraordinary USD 4.3 billion in revenue and a record USD 1.6 billion in pre-tax profit, while improving its cost-to-income ratio to 63%.

These results not only highlight the company’s operational efficiency but also mark a pivotal moment in its journey from challenger to global leader. The big question is: what’s fueling such impressive financial performance?

Customer Growth as the Core Driver

One of the clearest engines of revenue growth is Black Banx’s expanding customer base. By Q2 2025, the platform had reached 84 million clients worldwide, up from 69 million at the end of 2024. This 15 million net gain in six months demonstrates both the attractiveness of its services and the scalability of its model.

Unlike traditional banks, which rely heavily on branch expansion, Black Banx leverages digital-first onboarding that allows customers to open accounts within minutes using just a smartphone. This approach is especially effective in regions underserved by legacy institutions, where access to affordable financial tools is in high demand.

More customers don’t just mean higher transaction volumes—they generate a compounding effect where network size, brand trust, and service adoption reinforce one another.

Real-Time Payments and Cross-Border Solutions

A major contributor to Q2 revenues is the platform’s real-time payments infrastructure. Black Banx enables instant cross-border transfers across its 28 supported fiat currencies and multiple cryptocurrencies, helping both individuals and businesses bypass the traditional bottlenecks of international banking.

For freelancers, SMEs, and multinational clients, this means faster liquidity, reduced foreign exchange costs, and simplified global operations. The demand for real-time financial services is growing rapidly—Juniper Research projects global real-time payments turnover to hit USD 58 trillion by 2028—and Black Banx is strategically positioned to capture a significant share of this market.

Crypto Integration as a Revenue Stream

Another key revenue driver is crypto integration. While many traditional institutions remain hesitant, Black Banx embraced digital assets early and has built infrastructure to support Bitcoin, Ethereum, and the Lightning Network. In Q2 2025, 20% of all transactions on the platform were crypto-based, reflecting strong customer appetite for hybrid banking services that bridge fiat and digital assets.

Revenue comes not only from transaction fees but also from value-added services like crypto-to-fiat conversion, staking yields (4–12% APY), and blockchain-enabled payments. For customers in markets with unstable currencies, these services act as a financial lifeline, further expanding the platform’s relevance.

AI-Powered Efficiency and Risk Management

Record revenues would be less impressive if costs ballooned at the same rate. But Black Banx has proven adept at balancing growth with efficiency. Its cost-to-income ratio improved to 63% in Q2, down from 69% a year earlier, thanks to heavy reliance on AI-powered automation.

AI now drives fraud detection, compliance, and customer onboarding—areas where traditional banks often struggle with cost inefficiencies. By automating these processes, Black Banx can process millions of transactions securely while maintaining profitability at scale. This level of efficiency is rare in fintech, where high growth often comes at the expense of margins.

Regional Expansion and Untapped Markets

Geography also plays a role in fueling revenues. Much of the Q2 growth came from Africa, South Asia, and Latin America—regions where demand for mobile-first banking continues to soar. In 2024 alone, Black Banx reported a 32% increase in SME clients from the Middle East and Africa, signaling the strength of its positioning in underserved markets.

By extending services to populations previously excluded from formal banking—migrant workers, rural communities, and small businesses—Black Banx taps into vast pools of latent demand. The strategy proves that financial inclusion and profitability are not mutually exclusive but mutually reinforcing.

Diversified Revenue Streams

Another factor behind Q2’s record revenues is Black Banx’s diversified business model. Income is not tied to a single service but spread across multiple streams, including:

Transaction fees from cross-border transfers and payments.
Crypto trading and exchange services.
Premium account features for high-net-worth clients.
Corporate services for SMEs and international businesses.

This diversification insulates the company against volatility in any single segment, creating stable revenue growth even in shifting market conditions.

Michael Gastauer’s Strategic Blueprint

Behind these results is Michael Gastauer’s long-term strategy: scale aggressively but with efficiency, innovation, and inclusion at the core. His vision has always been to create a borderless financial ecosystem, and Q2 2025’s performance is evidence that this vision is not only achievable but sustainable.

By balancing mass-market accessibility with premium features, and by blending fiat with digital assets, Gastauer has positioned Black Banx as a category-defining player in global finance.

The Road Ahead: Toward 100 Million Clients

Looking forward, the company’s goal of reaching 100 million customers by the end of 2025 will likely be the next catalyst for revenue growth. More customers mean more transactions, more data insights, and more opportunities to refine and expand its service offering.

If current momentum holds, the USD 4.3 billion quarterly revenue milestone could be just the beginning of an even larger growth story. The challenge will be ensuring systems scale securely while maintaining trust in an environment where privacy and compliance are paramount.

A Record That Signals More to Come

Black Banx’s Q2 2025 performance—USD 4.3 billion in revenue, USD 1.6 billion in pre-tax profit, 84 million clients worldwide, and a lean 63% cost-to-income ratio—is more than a financial milestone. It is a signal of how the future of banking is being rewritten by platforms that are borderless, crypto-inclusive, and data-driven.

What fueled this record-breaking quarter is not one innovation but a combination of strategies—scalable onboarding, real-time payments, crypto integration, AI efficiency, and expansion into underserved regions. Together, they form a model that doesn’t just challenge traditional banking but actively builds the foundation for global dominance.

For Black Banx, the road ahead is clear: the $4.3 billion quarter is not an endpoint but a launchpad for even greater scale and profitability.