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.
Rf/Microwave Hyperthermia System, Cancer Treatment
Unknown
The RF/Microwave Hyperthermia System for Cancer Treatment is a therapeutic device used in conjunction with radiation therapy for the treatment of cervical carcinoma in patients who would normally receive combined chemotherapy and radiation but are ineligible for chemotherapy due to patient-related factors. It delivers radiofrequency or microwave energy to generate heat in tumor tissue, augmenting the effects of radiation. The device carries a device class of "f," indicating it follows a special or biological regulatory pathway, with no regulation number or standard medical specialty assigned; it was reviewed by the Obstetrics/Gynecology panel. It is not an implant and is not life-sustaining.
No 510(k) clearances found for "PAS". Try a different K-number, product code, or device name.
What 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.