FDA product code KMH: Sterilizer, Dry Heat
KMH is the FDA product code for sterilizer, dry heat. It is a Class II device, regulated under 21 CFR 880.6870 and reviewed by the General Hospital panel. FDA has cleared 10 510(k) submissions under KMH, from 6 different applicants. The average 510(k) review took 159 days (median 88).
Classification
| Field | Value |
|---|---|
| Device name | Sterilizer, Dry Heat |
| Device class | Class II |
| Regulation | 21 CFR 880.6870 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KMH clearance
Top KMH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cox Sterile Products, Inc. | 3 | 1992-05-08 |
| Cpac, Inc. | 2 | 2011-07-12 |
| Dentronix, Inc. | 2 | 1991-03-13 |
| Coltene/Whaledent, Inc. | 1 | 2005-08-04 |
| Lorvic Corp. | 1 | 1987-09-11 |
1 more applicants have KMH clearances. See the full list in Caduvo.
Most recent KMH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K094026 | Cpac, Inc. | STERI-DENT, STERI-SURE | 2011-07-12 | 559 |
| K051660 | Coltene/Whaledent, Inc. | DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM | 2005-08-04 | 43 |
| K910925 | Cox Sterile Products, Inc. | DISINFECTION WITH THE COX DRY HEAT STERILIZER | 1992-05-08 | 430 |
| K910202 | Dentronix, Inc. | DENTRONIX MODEL 2000 | 1991-03-13 | 62 |
| K880322 | Dentronix, Inc. | DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM | 1988-07-13 | 168 |
Recalls for KMH devices
openFDA lists no recalls for product code KMH.
Frequently asked questions
What is FDA product code KMH?
KMH is the FDA product code for sterilizer, dry heat. It is a Class II device, regulated under 21 CFR 880.6870 and reviewed by the General Hospital panel.
What device class is KMH?
Class II, regulation 21 CFR 880.6870. Typical premarket route: 510(k).
How long does a 510(k) take for product code KMH?
Across 10 cleared submissions the average was 159 days from receipt to decision (median 88).
Which companies have the most KMH clearances?
Cox Sterile Products, Inc. (3); Cpac, Inc. (2); Dentronix, Inc. (2); Coltene/Whaledent, Inc. (1); Lorvic Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KMH
- Run a recall and safety report across every KMH manufacturer
- Watch product code KMH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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