What is US FDA 510K?

FDA Medical Device Classification is different from the EU MDR classification. The classification method and criteria also differ. FDA 510k device classification depends on the intended use and indications of the use of the device. The US FDA has established classifications for approximately 1700 different generic types of devices and categorized them into 16 medical specialties. Each of these generic types of devices is assigned to one of the three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.

Class I – Low Risk (General Controls)

Devices are subjected to a comprehensive set of regulatory authorities called general controls that are applicable to all classes of devices.

  • Reusable surgical Instruments
  • Hospital Furniture
  • OT equipment
Class II – Moderate Risk (General Controls & Special Controls)

Devices for which general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance.

  • Urology Catheters
  • Patient Monitors
Class III – High Risk (General Controls & Pre-market approval)

Devices for which general controls, by themselves, are insufficient and for which there is insufficient information to establish special controls to provide reasonable assurance of safety and effectiveness of the device. Class III devices typically require pre-market approval(PMA).

  • PTCA Catheters
  • Stents / Heart Valves

Benefits of US FDA 510K

Reduced risk


Access to new business

Improved efficiency

Customer satisfaction

Helps you stand out from your competitors

Certified US FDA 510K Video

Who can be certified US FDA 510K?


Testing Kits

Medical Furniture

Medical Equipment

IVD Instruments

Surgical Instruments

Dental Implants

Ortho Implants

Disposable Syringes Needles

Document required for US FDA 510K

510(k) Documentation includes but not limited to the following:
  • Identify Device Class, product code, and Regulation
  • Appropriate Predicate device Identification
  • Identify Appropriate guidance and control documents
  • Choosing an appropriate type* of 510(k) submission
  • Prepare Indication for Use statement
  • Declaration of Conformity
  • Identification of Biocompatibility tests
  • Identification of Performance test
  • Sampling Plan
  • Requirements for stability studies
  • Review of the Risk management file
  • Sterilization requirements and appropriate documentation
  • Labeling requirements and review of label
  • 510(k) summary and predicate comparison
  • Identify any clinical data/ test requirements
  • Device-specific documentation requirements- includes Software, EMC, and Electrical safety
  • Review of Final 510(k) File
  • Pre-submission (Q-submission)
  • Refuse to Accept Policy for 510(k) acceptance review
  • E-copy Submission
  • Interact with FDA – Answering Review Comments and Additional Information requirement during the post submission phase.
  • Device Listing and Registration
  • US Agent Services

The extent of Documented Information differs as per:

  • Product and it's uses
  • Testing requirement of products
  • Directive in which product classified
  • Self Certification or Compliance Certification
  • Notify body Certificate

Role of Shamkris and Process of US FDA 510K

Shamkris adopts a results-oriented approach to compliance product certification, A simple & practical method of product certification organization in timely compliance and fulfills the product certification requirement. Shamkris support 100% on documentation required to comply with product certification either by self-certification or notify body certification to depend on directives.

The implementation process is described below:

Step 1

Phase I

• Selecting the Medical Device and Models for USFDA approval

Step 2

Phase II

• Identify device code and Regulation Number along with verification of predicate device, indication and technology

Step 3

Phase III

• 510K compilation incorporating the pre-submission

Step 4

Phase IV

• US Agent appointment

Step 5

Phase V

• Modify the 510K and provide additional supporting documentary evidences as per FDA review comments.

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.

The predicate device is a legally marketed, 510(k) cleared device used to determine substantial equivalence of the proposed/new device for510(k) Submission is called proposed predicate device. Yes, it is necessary to submit to FDA, as the substantial equivalence of the proposed device with a legally marketed device decides the 510(k) clearance. It is a critical part of 510(k) you should include a comparison table and discussion of the similarities and differences of your device compared to one or more predicate devices to which you are claiming equivalency.

Using the Acceptance Checklist appropriate to the submission type (traditional, abbreviated, or special), within 15 calendar days of receipt of the 510(k), FDA staff should answer each question for the elements identified as RTA (Refuse to Accept) items. We do have the PDF version of the acceptance checklist for traditional as well as abbreviated. It can be used internally to ensure all the sections are included in the documentation during submission.

• False or misleading labels
• labeling that fails to provide the mandatory information under FDA regulations
• Not properly display the mandatory information
• Labeling that violates the Poison Prevention Packaging Act.

FDA recommends the evaluation of biocompatibility of tissue contacting materials if the medical device contains components that come into direct or indirect contact with tissue. Biocompatibility testing is performed as per the standard ISO 10993-1. The biocompatibility studies shall perform even if the material and construction of the subject device and predicate device are the same, to prove the biological safety of the device. The reviewer will need information regarding detailed testing protocol and reports. The protocol shall include the details of study title and standard, the test article preparation, detailed test method- positive and negative controls, test parameters and acceptance criteria, analysis of results. The report shall include the analysis of test results, conclusions made from the test result, device photograph, etc.

Sterilization validation is required for only sterile medical devices. The section for sterility can be not applicable for non-sterile medical devices. FDA released two guidance for the Sterility Information in Premarket Notification 510(k) Submissions for Devices Labelled as Sterile and Reprocessed Single-Use Medical Devices.