Atlas FDA

KMH

10 FDA 510(k) clearances · Product code

115 daysmedian time to decision
559 days90th percentile
10clearances measured

FDA profile

Official device name
Sterilizer, Dry Heat
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6870
Medical specialty
General Hospital
Flags
Third-party review eligible
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RecordFirmDate
STERI-DENT, STERI-SURE (K094026)Cpac, Inc.2011-07-12
DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM (K051660)Coltene/Whaledent, Inc.2005-08-04
DISINFECTION WITH THE COX DRY HEAT STERILIZER (K910925)Cox Sterile Products, Inc.1992-05-08
DENTRONIX MODEL 2000 (K910202)Dentronix, Inc.1991-03-13
DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM (K880322)Dentronix, Inc.1988-07-13
COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE (K881371)Cox Sterile Products, Inc.1988-04-13
COX RAPID HEAT TRANSFER STERILIZER (K872643)Cox Sterile Products, Inc.1987-10-29
U. V. GERMICIDAL UNIT (K871615)Lorvic Corp.1987-09-11
INOX DRY HEAT STERILIZER (K851307)Broadwest Corp.1985-05-09
DRY HEAT STERILIZER (K771070)Cpac, Inc.1977-07-14

Track KMH automatically

Every clearance here is in the API, with alerts when new ones post.