When a company wants to advertise that their product is “FDA Cleared,” they must adhere to specific guidelines set by the U.S. Food and Drug Administration (FDA) to ensure the claim is accurate and not misleading. The term “FDA Cleared” typically refers to medical devices that have undergone the FDA’s 510(k) premarket notification process, in which the FDA makes its determination for the marketed device.
The term “FDA Cleared” should only be used for medical devices that have received 510(k) clearance. It should not be used for products that are only registered or listed with the FDA.
ChiroSight is the dba under Biokinemetrics, Inc. Both names are FDA Cleared and are listed on the FDA website for 510(k) clearance for numerous digital x-ray and related software application devices.
These clearances were achieved through rigorous evaluation and inspection. ChiroSight undergoes an annual on-site inspection and evaluation of the processes and procedures related to the medical devices (equipment and software). This quality management is important for the safety of medical device products.
Other companies who claim FDA Cleared may have mistakenly made the claim without undergoing annual inspection or audits of the medical device to maintain their products’ safety and meet audit criteria.
If you cannot find the name of the company or the product claiming to be FDA Cleared on the FDA website, then that company may be incorrectly using the term and not actually inspected for the medical device or software.
The advertising must not imply that the FDA endorses or guarantees the product’s safety or effectiveness. The FDA clearance process only confirms that the device is substantially equivalent to an already legally marketed device; it does not mean the FDA has fully tested the product.
To determine if a medical device has completed the FDA’s 510(k) premarket notification process, there are several steps you can follow. The FDA maintains publicly accessible databases and resources that allow you to verify the clearance status of a medical device. Here is how to check:
Use the FDA’s 510(k) Database
The FDA has a specific 510(k) Premarket Notification Database, where you can search for devices that have gone through and received 510(k) clearance.
Steps to use the database:
- Visit the FDA 510(k) Database.
- You can search by:
- Device name
- Company name (applicant/sponsor)
- 510(k) number (if known)
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
Check FDA Establishment Registration and Device Listing Database
The FDA also maintains a Device Registration and Listing Database, where you can search for manufacturers that are registered with the FDA and see which devices they have listed.
Visit the Establishment Registration & Device Listing Database and search for the manufacturer or product.
Request Documentation from the Manufacturer
If you are unable to find the device in the FDA’s databases, you can ask the manufacturer or distributor directly for the 510(k) number. Once you have the number, you can verify it using the FDA’s 510(k) database.
Use the FDA’s Medical Device Classification Database
The FDA also has a Medical Device Classification Database where you can check the classification of a product and determine if a 510(k) clearance is required for that type of device.
Visit the Medical Device Classification Database to see if the device type generally requires 510(k) clearance.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
Here are some reasons why you might not find the product or company name:
- Different Product Name in the FDA Database
The name in the FDA database could be a generic device name or a technical description, not the brand name or the marketed name. For example, a branded device called “Super Heart Monitor” might be listed under a generic name like “Electrocardiograph.”Try searching by device category, classification, or product code instead of the commercial name. - Parent Company or Distributor Listed Instead of the Brand Name
If a company uses a distributor or is owned by a parent company, the 510(k) clearance may be listed under that company’s name. For instance, a product marketed by a brand may be cleared under the parent company that owns the brand.Search using the legal or parent company’s name to locate the 510(k) clearance.
If you are still unable to locate any information, it could raise concerns about whether the “FDA Cleared” claim is valid.
FDA’s Medical Device Exemptions Database
- Establishment Registration & Device Listing Database
- Medical Device Classification Database
Some medical devices are 510(k) exempt, meaning they do not need to undergo the 510(k)-clearance process. These include many low-risk Class I and some Class II devices, such as bandages, tongue depressors, or some software-based products.
If the product is exempt from 510(k) requirements, it would not appear in the 510(k) database. However, the company cannot claim “FDA Cleared” in this case because they did not go through the 510(k) process.
Here are the Biokinemetrics, Inc. dba ChiroSight medical device 510(k) listings at FDA:
Biokinemetrics, Inc. also is listed on Health Canada (the equivalent to FDA in the USA).
FDA Registration Information
FDA Registration Number: 3013714596
Owner Operator Number: 10050908
BIOKINEMETRICS INC.
211 E. 4th St.
Carroll, IA 51401
UNITED STATES
CDRH Registration and Listing Helpdesk
Imports and Registration & Listing Team
Division of Establishment Support
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
U.S. Food and Drug Administration