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 880.6991](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6991) → LDS — Device, Pasteurization, Hot Water

# LDS · Device, Pasteurization, Hot Water

_General Hospital · 21 CFR 880.6991 · Class 2_

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

## Overview

- **Product Code:** LDS
- **Device Name:** Device, Pasteurization, Hot Water
- **Regulation:** [21 CFR 880.6991](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6991)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

A medical washer is a device that is intended for general medical purposes to clean 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.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

## 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.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K183444](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LDS/K183444.md) | Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector | Cenorin, LLC | Sep 9, 2019 | SESE |
| [K031799](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LDS/K031799.md) | MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 | Miele, Inc. | Nov 12, 2003 | SESE |
| [K983068](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LDS/K983068.md) | RELIANCE FAMILY OF WASHER-DISINFECTORS | STERIS Corporation | May 31, 2000 | SESE |
| [K972193](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LDS/K972193.md) | OLYMPIX MINI-PASTEURMATIC (58210) | Olympic Medical Corp. | Sep 5, 1997 | SESE |
| [K950518](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LDS/K950518.md) | MIELE G 7781 DENTAL THERMAL DISINFECTOR | Miele Professional | Jan 26, 1996 | SESE |
| [K950566](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LDS/K950566.md) | DECOMAT 4656 | Getinge Disinfection, Inc. | Oct 19, 1995 | SESE |
| [K953645](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LDS/K953645.md) | OLYMPIC PASTEURMATIC SYSTEM | Olympic Medical Corp. | Sep 22, 1995 | SESE |
| [K884151](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LDS/K884151.md) | MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU. | Miele Appliances, Inc. | May 16, 1989 | SESE |
| [K860263](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LDS/K860263.md) | CASTLE 7538 FLOOR LOADING WASHER | Castle Co. | Mar 5, 1986 | SESE |
| [K844089](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LDS/K844089.md) | CASTLE 7515 UTENSIL/GLASSWARE WASHER | Castle Co. | Jan 14, 1985 | SESE |
| [K810311](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LDS/K810311.md) | STERI-VERS | The Hilrad Co. | Apr 17, 1981 | SESE |

## Top Applicants

- Castle Co. — 2 clearances
- Olympic Medical Corp. — 2 clearances
- Cenorin, LLC — 1 clearance
- Getinge Disinfection, Inc. — 1 clearance
- Miele Appliances, Inc. — 1 clearance

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

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