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.
Pack, Hot Or Cold, Reusable
Physical Medicine
A Reusable Hot or Cold Pack is a Physical Medicine thermal therapy device designed for repeated use, typically filled with a gel or granular material that retains temperature after heating or freezing, applied to the body for localized heat or cold therapy to relieve pain and reduce inflammation. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IME, regulated under 21 CFR 890.5700, within the Physical Medicine medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.
510(k) Clearances
27 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.