510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Hydrogel Spacer
Radiology
The Hydrogel Spacer (product code OVB) is a biodegradable implant injected into the perirectal space to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer, with the intent of reducing the radiation dose delivered to the anterior rectum. The spacer maintains its position throughout the full course of prostate radiotherapy and is completely absorbed by the body over time. As an FDA Class 2 device under regulation 892.5725, it requires 510(k) premarket clearance and falls within the Radiology specialty. The device is not explicitly flagged as an implant in this record and is not life-sustaining.
510(k) Clearances
6 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.