Regulations
233
Product codes
588
Devices
10,117
Device class distribution
Class I
3,363 (33.2%)
Class II
6,754 (66.8%)
Top product codes by device count
CodeExample deviceDevices
JWY ETEST Gepotidacin (GEP) (0.016-256 µg/mL) 441
JTN Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 327
JSJ POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 307
LON VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance 289
JSI BBL CHROMAGAR 0157 285
DHB NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg 264
JTO IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT 244
JSG THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 209
LLL Alegria Flash CTD Screen 180
JSH UREA BROTH 146
DHR K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) 144
DCK K-ASSAY CRP (Ver.2) 126
DGC Kenota 1 Total IgE; Kenota 1 (instrument) 114
LJM EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay 112
LSR Lyme-ID IgG Test; Bio-ID800 111
Researching a predicate in this panel?
Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.
Start free trial →

Everything you need for a 510(k) submission. Nothing you don't.

14-day free trial. No setup. Cancel anytime.

Start free trial →
Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →