Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

KMH — Predicate Candidate Screening

10 FDA 510(k) clearances under this product code; the 50 most recent screened below.

115 daysmedian FDA review time
559 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K094026STERI-DENT, STERI-SURECpac, Inc.2011-07-125590
K051660DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SColtene/Whaledent, Inc.2005-08-04430
K910925DISINFECTION WITH THE COX DRY HEAT STERILIZERCox Sterile Products, Inc.1992-05-084300
K910202DENTRONIX MODEL 2000Dentronix, Inc.1991-03-13620
K880322DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEMDentronix, Inc.1988-07-131680
K881371COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLECox Sterile Products, Inc.1988-04-13120
K872643COX RAPID HEAT TRANSFER STERILIZERCox Sterile Products, Inc.1987-10-291150
K871615U. V. GERMICIDAL UNITLorvic Corp.1987-09-111370
K851307INOX DRY HEAT STERILIZERBroadwest Corp.1985-05-09380
K771070DRY HEAT STERILIZERCpac, Inc.1977-07-14300

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda