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 880.6992](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6992) → MDZ — Cleaners, Medical Devices

# MDZ · Cleaners, Medical Devices

_General Hospital · 21 CFR 880.6992 · Class 2_

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

## Overview

- **Product Code:** MDZ
- **Device Name:** Cleaners, Medical Devices
- **Regulation:** [21 CFR 880.6992](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6992)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)
- **3rd-party reviewable:** yes

## Identification

A medical washer-disinfector is a device that is intended for general medical purposes to clean, decontaminate, disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.

## Classification Rationale

Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors.”

## Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors.”(1) Medical washer-disinfectors that are intended to clean, high level disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.
(2) Medical washer-disinfectors that are intended to clean, low or intermediate level disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K920413](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MDZ/K920413.md) | DECOMAT A 8666 | Getinge International, Inc. | Apr 5, 1994 | SESE |
| [K920406](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MDZ/K920406.md) | DECOMAT 228 | Getinge International, Inc. | Apr 5, 1994 | SESE |

## Top Applicants

- Getinge International, Inc. — 2 clearances

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

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