Sterilizer, Dry Heat
A Dry Heat Sterilizer is a device used in healthcare and laboratory settings that uses elevated dry heat (typically 160 to 180 degrees Celsius) to sterilize reusable instruments and equipment by destroying microorganisms through thermal oxidation. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KMH and the applicable regulation is 21 CFR 880.6870 in the General Hospital specialty. This device is eligible for third-party review.
Research product code KMH in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- KMH
- Device Class
- FDA class 2
- Regulation Number
- 880.6870
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K094026 | STERI-DENT, STERI-SURE | Jul 12, 2011 | Substantially Equivalent | Cpac, Inc. |
| K051660 | DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM | Aug 04, 2005 | Substantially Equivalent | Coltene/Whaledent, Inc. |
| K910925 | DISINFECTION WITH THE COX DRY HEAT STERILIZER | May 08, 1992 | Substantially Equivalent | Cox Sterile Products, Inc. |
| K910202 | DENTRONIX MODEL 2000 | Mar 13, 1991 | Substantially Equivalent | Dentronix, Inc. |
| K880322 | DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM | Jul 13, 1988 | Substantially Equivalent | Dentronix, Inc. |
| K881371 | COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE | Apr 13, 1988 | Substantially Equivalent | Cox Sterile Products, Inc. |
| K872643 | COX RAPID HEAT TRANSFER STERILIZER | Oct 29, 1987 | Substantially Equivalent | Cox Sterile Products, Inc. |
| K871615 | U. V. GERMICIDAL UNIT | Sep 11, 1987 | Substantially Equivalent | Lorvic Corp. |
| K851307 | INOX DRY HEAT STERILIZER | May 09, 1985 | Substantially Equivalent | Broadwest Corp. |
| K771070 | DRY HEAT STERILIZER | Jul 14, 1977 | Substantially Equivalent | Cpac, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.