How to Identify a Predicate Device for 510(k) Notification
14 Apr 2025A predicate device is defined as a medical device previously approved by the US Food And Drug Administration (US FDA) that is already on the market. A recently cleared 510(k) device is commonly chosen as a predicate. However, any device that is legally marketed in the U.S. can serve this role. This includes devices cleared through 510(k), those marketed before May 28, 1976 (known as pre-amendment devices), devices initially approved as Class III through Pre-market Approval and later reclassified to Class II or I, as well as devices exempt from the 510(k) requirement.
The search for a predicate device for 510(k) notification is a crucial step in obtaining marketing authorization for a new medical device (subject device) in the United States.
Determining the Substantial Equivalence for the Subject Device
For the Pre-market Notification 510(k),the submitters have to show that the subject device is safe and effective to a predicate device by proving substantial equivalence.
A claim of substantial equivalence does not mean the subject device(s) must be identical to the predicate devices. A new device is substantially equivalent if:
- It has the same intended use as the predicate device;
- It has the same technological characteristics as the predicate device or, if different, these differences do not raise recent issues in terms of safety and efficacy.
How to search a Predicate Device
The FDA 510(k) database includes all medical devices that have received market clearance through the 510(k) process. When searching for a predicate device, it is essential to understand the classification of the subject device and its corresponding product code. The classification can be found using the Product Code Classification Database, that provides:
- The classification panel (e.g. orthopedic device)
- Common name
- Product code
- CFR regulation
Additional Information on classification and product code can be found in “Classify your Medical Device”.
FDA’s database provides a three-letter product code for each device classification. Devices with similar functions are often grouped under the same product code in the 510(k) database. Thus, searching by product code is typically the most reliable method.
How to Determine if a Device is a Predicate Device
Several factors can be helpful in determining a device as a predicate device. These include:
- Biocompatibility Assessments: Whenever the biocompatibility assessments are performed on a device or its components, they should not be limited to the raw materials used in device’s manufacturing processing. Instead, additional chemicals should also be considered. However, this is not applicable to the In-vitro medical devices.
- Technological Characteristics: The technological characteristics of the predicate device must be identical to the new device. For example, materials, design, and the mode of operation of the subject device must be like the predicate device.
- Use of the Latest Technology: The predicate device must possess the latest technology, it should not be dated.
- Intended Use: The intended use of the predicate device and the new device must be similar. For example, if the predicate device is designed for blood glucose measurement, then the new devices should also be intended for the same use.
The predicate device can be quite helpful for medical device manufacturers, as it can bring newer devices to the market via the 510(k) pathway. If chosen correctly, the predicate device can make it quite easy for the medical device manufacturers to place and market their new device, with reduced costs and time required to place the device on the market.
In contrast, if a manufacturer selects the wrong predicate device for this purpose, it could cause expensive, hectic, and time-consuming regulatory approval processes.
To save the manufacturers from this ordeal, our experts at TSQ&E can be of great help. We have ample knowledge and expertise in the regulator matters concerning the US FDA. Not only can we help you find the right predicate device for your new product, but we can also ensure that it swiftly passes through the FDA’s approval processes.
A 510(k) notification is a regulatory application that a company submits to the to get marketing authorization for a medical device in the United States. TS Quality & Engineering can help you with this process of identifying a predicate device for 510k submission, so get connected through online form.
