Business

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

Published

3 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

High Volume, High Value: The Business Logic Behind Black Banx’s Growth

Published

4 days ago

June 16, 2025

Matthew Wiles

In fintech, success no longer hinges on legacy prestige or brick-and-mortar branches—it’s about speed, scale, and precision. Black Banx, under the leadership of founder and CEO Michael Gastauer, has exemplified this model, turning its high-volume approach into high-value results.

The company’s Q1 2025 performance tells the story: $1.6 billion in pre-tax profit, $4.3 billion in revenue, and 9 million new customers added, bringing its total customer base to 78 million across 180+ countries.

But behind the numbers lies a carefully calibrated business model built for exponential growth. Here’s how Black Banx’s strategy of scale is redefining what profitable banking looks like in the digital age.

Scaling at Speed: Why Volume Matters

Unlike traditional banks, which often focus on deepening relationships with a limited set of customers, Black Banx thrives on breadth and transactional frequency. Its digital infrastructure supports onboarding millions of users instantly, with zero physical presence required. Customers can open accounts within minutes and transact across 28 fiat currencies and 2 cryptocurrencies (Bitcoin and Ethereum) from anywhere in the world.

Each customer interaction—whether it’s a cross-border transfer, crypto exchange, or FX transaction—feeds directly into Black Banx’s revenue engine. At scale, these micro-interactions yield macro results.

Real-Time, Global Payments at the Core

One of Black Banx’s most powerful value propositions is real-time cross-border payments. By enabling instant fund transfers across currencies and countries, the platform removes the frictions associated with SWIFT-based systems and legacy banking networks.

This service, used by individuals and businesses alike, generates:

Volume-based revenue from transaction fees
Exchange spreads on currency conversion
Premium service income from business clients managing international payroll or vendor payments

With operations in underserved regions like Africa, South Asia, and Latin America, Black Banx is not only increasing volume—it’s tapping into fast-growing financial ecosystems overlooked by legacy banks.

The Flywheel Effect of Crypto Integration

Crypto capabilities have added another dimension to the company’s high-volume model. As of Q1 2025, 20% of all Black Banx transactions involved cryptocurrency, including:

Crypto-to-fiat and fiat-to-crypto exchanges
Crypto deposits and withdrawals
Payments using Bitcoin or Ethereum

The crypto integration attracts both retail users and blockchain-native businesses, enabling them to:

Access traditional banking rails
Convert assets seamlessly
Operate with lower transaction fees than those found in standard financial systems

By being one of the few regulated platforms offering full banking and crypto support, Black Banx is monetizing the convergence of two financial worlds.

Optimized for Operational Efficiency

High volume is only profitable when costs are contained—and Black Banx has engineered its operations to be lean from day one. With a cost-to-income ratio of just 63% in Q1 2025, it operates significantly more efficiently than most global banks.

Key enablers of this cost efficiency include:

AI-driven compliance and customer support
Cloud-native architecture
Automated onboarding and KYC processes
Digital-only servicing without expensive physical infrastructure

The outcome is a platform that not only scales, but does so without sacrificing margin—each new customer contributes to profit rather than diluting it.

Business Clients: The Value Multiplier

While Black Banx’s massive customer base is largely consumer-driven, its business clients are high-value accelerators. From SMEs and startups to crypto firms and global freelancers, businesses use Black Banx for:

International transactions
Multi-currency payroll
Crypto-fiat settlements
Supplier payments and invoicing

These clients tend to:

Transact more frequently
Use a broader range of services
Generate significantly higher revenue per user

Moreover, Black Banx’s API integrations and tailored enterprise solutions lock in these clients for the long term, reinforcing predictable and scalable growth.

Monetizing the Ecosystem, Not Just the Account

The genius of Black Banx’s model is that it monetizes not just accounts, but entire customer journeys. A user might:

Onboard in minutes
Deposit funds from a crypto wallet
Exchange currencies
Pay an overseas vendor
Withdraw to a local bank account

Each of these actions touches a different monetization lever—FX spread, transaction fee, crypto conversion, or premium service charge. With 78 million customers doing variations of this at global scale, the cumulative financial impact becomes immense.

Strategic Expansion, Not Blind Growth

Unlike many fintechs that chase customer acquisition without a clear monetization path, Black Banx aligns its growth with strategic market opportunities. Its expansion into underbanked and high-demand markets ensures that:

Customer acquisition costs stay low
Services meet genuine needs (e.g., cross-border income, crypto access)
Revenue per user grows over time

It’s not just about acquiring more customers—it’s about acquiring the right customers, in the right markets, with the right needs.

The Future Belongs to Scalable Banking

Black Banx’s ability to transform high-volume engagement into high-value profitability is more than just a fintech success—it’s a signal of what the future of banking looks like. In a world where agility, efficiency, and inclusion define competitive advantage, Black Banx has created a blueprint for digital banking dominance.

With $1.6 billion in quarterly profit, nearly 80 million users, and services that span the globe and the blockchain, the company is no longer just scaling—it’s compounding. Each new user, each transaction, and each feature builds upon the last.

This is not the story of a bank growing.

This is the story of a bank accelerating.