FDA 510(k) Clearance for Medical Devices & IVDs

• FDA 510(k) clearance is a regulatory pathway that allows medical device manufacturers to demonstrate that their product is substantially equivalent to an already legally marketed device in the United States. This process is essential for organizations aiming to introduce Class I (non-exempt), Class II, or certain Class III devices—intended for human use—without undergoing the more rigorous Pre-Market Approval (PMA) process.
• While most Class I devices are exempt from 510(k) requirements, others must undergo a formal review. Once the FDA determines your device is substantially equivalent to a predicate, it will issue a 510(k) clearance along with a unique ‘K’ number, authorizing market entry. At RAPS, we offer comprehensive regulatory support throughout the 510(k) process. Our services include:
• Identifying the most appropriate predicate device
   
• Determining the correct regulation number and device code
   
• Preparing and formatting the full 510(k) submission, including eCopy conversion
   
• Submitting to the FDA via our US Agent service
   
• Assisting with pre-submission (Q-Submission) strategies, when applicable
   

Whether you're launching a new device or modifying an existing one, our expert team ensures your submission is complete, compliant, and strategically aligned with FDA expectations—maximizing your chances of a swift clearance.

• Trusted FDA 510(k) Consultants — End-to-End Support You Can Rely On
• At RAPS, we’ve built a global reputation as a trusted partner for FDA 510(k) submissions, supporting over 350 manufacturers and specification developers across a wide range of medical technologies. Our team of seasoned regulatory experts delivers tailored, end-to-end consulting solutions—regardless of your company’s size or internal regulatory expertise.
• With an 85% success rate and more than 350 FDA 510(k) clearances achieved since 1999, we combine technical precision with decades of experience to ensure your submission is both accurate and strategically sound.
• What sets us apart:
• Hands-on File Preparation – We don’t just advise; we take full ownership of the 510(k) process from start to finish.
   
• Comprehensive Support – From identifying predicates to managing eCopy formatting, our experts handle every detail.
   
• Commitment to Results – We remain engaged until your FDA clearance is secured—your success is our responsibility.
   
• Cost-Effective Excellence – High-quality service at a competitive cost, backed by a proven track record.
   
• Partner with RAPS for a smoother, faster, and more confident path to 510(k) approval.

• Types of FDA 510(k) Submissions
• The FDA 510(k) clearance process offers three distinct submission types—Traditional, Abbreviated, and Special—each designed to accommodate different device scenarios and regulatory pathways. Regardless of the type selected, the core requirement remains the same: the manufacturer must demonstrate substantial equivalence to a legally marketed (predicate) device.
• Traditional 510(k)
• The Traditional 510(k) is the most commonly used and comprehensive submission type. It applies to:
• New devices requiring FDA clearance
   
• Modifications to previously cleared devices
   
• This pathway requires detailed documentation across all applicable areas, including device design, performance, safety, biocompatibility, and more. The FDA typically reviews Traditional 510(k) submissions within 90 calendar days.
• Abbreviated 510(k)
• The Abbreviated 510(k) streamlines the submission process when:
• FDA guidance documents are available for the device type
   
• Recognized consensus standards or special controls exist
   
• In addition to core data, this format emphasizes the use of FDA-recognized standards and regulatory guidance to support the claim of substantial equivalence.
• Special 510(k)
• The Special 510(k) is intended for modifications to an existing, already-cleared device where:
• The changes do not impact the device’s intended use or fundamental technology
   
• Established testing methods can validate safety and effectiveness
   
• This submission type is ideal for minor changes such as updates to labeling, indications for use, or component design—allowing for a more focused and expedited review process.

• What Is a Predicate Device?
• A predicate device is a legally marketed medical device in the United States—cleared through either the FDA 510(k) or PMA process—that serves as a benchmark for comparing a new device. To qualify as a predicate, the device must have:
• The same intended use
   
• Similar indications for use
   
• Comparable technological characteristics
   
• Importantly, the predicate device should be a single product currently available on the U.S. market and must not have been subject to recent product recalls. Selecting the right predicate is a critical step in the 510(k) submission process, as it forms the basis for demonstrating substantial equivalence.
• What Is Substantial Equivalence?
• Substantial equivalence is the cornerstone of the FDA 510(k) clearance process. It means that your device is at least as safe and effective as a legally marketed predicate device with similar intended use and technological characteristics.
• To establish substantial equivalence, your device must meet key criteria, which may include:
• Intended use
   
• Design and engineering
   
• Safety and risk profile
   
• Compliance with applicable standards
   
• Labeling and instructions for use
   
• Biocompatibility
   
• Performance and functional testing
   
• Materials and chemical composition
   
• Manufacturing methods and controls
   
• Demonstrating substantial equivalence assures the FDA that your device does not raise new safety or effectiveness concerns compared to an existing product on the market.

• Difference Between 510k Clearance, Approval & Granted
• The language used by the Food and Drug Administration, often varies depending on the associated risk levels of the products they regulate. Generally, the FDA employs different terminology and regulatory requirements for products based on their risk levels, to ensure appropriate oversight and consumer protection
• Clearance: When a medical device has undergone a 510k submission, which the FDA has reviewed and provided FDA 510k clearance.
• Approval: For Class III medical devices rigorous review and successful submission of a premarket approval (PMA), the device is given Approval.
• Granted: Medical devices using the De Novo pathway must be Granted by the FDA before they can be legally marketed in the United States.