LDS · Device, Pasteurization, Hot Water
General Hospital · 21 CFR 880.6991 · Class 2
Overview
| Product Code | LDS |
|---|---|
| Device Name | Device, Pasteurization, Hot Water |
| Regulation | 21 CFR 880.6991 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
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 | Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector | Cenorin, LLC | Sep 9, 2019 | SESE |
| K031799 | MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 | Miele, Inc. | Nov 12, 2003 | SESE |
| K983068 | RELIANCE FAMILY OF WASHER-DISINFECTORS | STERIS Corporation | May 31, 2000 | SESE |
| K972193 | OLYMPIX MINI-PASTEURMATIC (58210) | Olympic Medical Corp. | Sep 5, 1997 | SESE |
| K950518 | MIELE G 7781 DENTAL THERMAL DISINFECTOR | Miele Professional | Jan 26, 1996 | SESE |
| K950566 | DECOMAT 4656 | Getinge Disinfection, Inc. | Oct 19, 1995 | SESE |
| K953645 | OLYMPIC PASTEURMATIC SYSTEM | Olympic Medical Corp. | Sep 22, 1995 | SESE |
| K884151 | MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU. | Miele Appliances, Inc. | May 16, 1989 | SESE |
| K860263 | CASTLE 7538 FLOOR LOADING WASHER | Castle Co. | Mar 5, 1986 | SESE |
| K844089 | CASTLE 7515 UTENSIL/GLASSWARE WASHER | Castle Co. | Jan 14, 1985 | SESE |
| K810311 | 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
