Product code KMH— General Hospital

FDA has cleared 10 devices under product code KMH between 1977 and 2011, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20111 clearance
• 20051 clearance
• 19921 clearance
• 19911 clearance
• 19882 clearances
• 19872 clearances
• 19851 clearance
• 19771 clearance

• Cox Sterile Products, Inc.3 clearances
• Dentronix, Inc.2 clearances
• Cpac, Inc.2 clearances
• Lorvic Corp.1 clearance
• Coltene/Whaledent, Inc.1 clearance
• Broadwest Corp.1 clearance

• K094026 — STERI-DENT, STERI-SURECpac, Inc.·2011-07-12
• K051660 — DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEMColtene/Whaledent, Inc.·2005-08-04
• K910925 — DISINFECTION WITH THE COX DRY HEAT STERILIZERCox Sterile Products, Inc.·1992-05-08
• K910202 — DENTRONIX MODEL 2000Dentronix, Inc.·1991-03-13
• K880322 — DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEMDentronix, Inc.·1988-07-13
• K881371 — COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLECox Sterile Products, Inc.·1988-04-13
• K872643 — COX RAPID HEAT TRANSFER STERILIZERCox Sterile Products, Inc.·1987-10-29
• K871615 — U. V. GERMICIDAL UNITLorvic Corp.·1987-09-11
• K851307 — INOX DRY HEAT STERILIZERBroadwest Corp.·1985-05-09
• K771070 — DRY HEAT STERILIZERCpac, Inc.·1977-07-14