Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6870](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6870) → KMH — Sterilizer, Dry Heat

# KMH · Sterilizer, Dry Heat

_General Hospital · 21 CFR 880.6870 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMH

## Overview

- **Product Code:** KMH
- **Device Name:** Sterilizer, Dry Heat
- **Regulation:** [21 CFR 880.6870](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6870)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)
- **3rd-party reviewable:** yes

## Identification

A dry-heat sterilizer is a device that is intended for use by a health care provider to sterilize medical products by means of dry heat.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K094026](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMH/K094026.md) | STERI-DENT, STERI-SURE | Cpac, Inc. | Jul 12, 2011 | SESE |
| [K051660](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMH/K051660.md) | DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM | Coltene/Whaledent, Inc. | Aug 4, 2005 | SESE |
| [K910925](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMH/K910925.md) | DISINFECTION WITH THE COX DRY HEAT STERILIZER | Cox Sterile Products, Inc. | May 8, 1992 | SESE |
| [K910202](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMH/K910202.md) | DENTRONIX MODEL 2000 | Dentronix, Inc. | Mar 13, 1991 | SESE |
| [K880322](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMH/K880322.md) | DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM | Dentronix, Inc. | Jul 13, 1988 | SESE |
| [K881371](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMH/K881371.md) | COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE | Cox Sterile Products, Inc. | Apr 13, 1988 | SESE |
| [K872643](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMH/K872643.md) | COX RAPID HEAT TRANSFER STERILIZER | Cox Sterile Products, Inc. | Oct 29, 1987 | SESE |
| [K871615](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMH/K871615.md) | U. V. GERMICIDAL UNIT | Lorvic Corp. | Sep 11, 1987 | SESE |
| [K851307](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMH/K851307.md) | INOX DRY HEAT STERILIZER | Broadwest Corp. | May 9, 1985 | SESE |
| [K771070](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMH/K771070.md) | DRY HEAT STERILIZER | Cpac, Inc. | Jul 14, 1977 | SESE |

## Top Applicants

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

---

**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMH](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMH)

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