Device, Pasteurization, Hot Water
A hot water pasteurization device is a hospital or clinical use device that uses heated water to pasteurize respiratory therapy equipment, feeding tubes, or other reusable medical components, reducing microbial contamination between uses. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is LDS, regulated under 21 CFR 880.6991, in the General Hospital specialty. No special risk flags apply.
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Basic Information
- Product Code
- LDS
- Device Class
- FDA class 2
- Regulation Number
- 880.6991
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K183444 | Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector | Sep 09, 2019 | Substantially Equivalent | Cenorin, LLC |
| K031799 | MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 | Nov 12, 2003 | Substantially Equivalent | Miele, Inc. |
| K983068 | RELIANCE FAMILY OF WASHER-DISINFECTORS | May 31, 2000 | Substantially Equivalent | STERIS Corporation |
| K972193 | OLYMPIX MINI-PASTEURMATIC (58210) | Sep 05, 1997 | Substantially Equivalent | Olympic Medical Corp. |
| K950518 | MIELE G 7781 DENTAL THERMAL DISINFECTOR | Jan 26, 1996 | Substantially Equivalent | Miele Professional |
| K950566 | DECOMAT 4656 | Oct 19, 1995 | Substantially Equivalent | Getinge Disinfection, Inc. |
| K953645 | OLYMPIC PASTEURMATIC SYSTEM | Sep 22, 1995 | Substantially Equivalent | Olympic Medical Corp. |
| K884151 | MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU. | May 16, 1989 | Substantially Equivalent | Miele Appliances, Inc. |
| K860263 | CASTLE 7538 FLOOR LOADING WASHER | Mar 05, 1986 | Substantially Equivalent | Castle Co. |
| K844089 | CASTLE 7515 UTENSIL/GLASSWARE WASHER | Jan 14, 1985 | Substantially Equivalent | Castle Co. |
| K810311 | STERI-VERS | Apr 17, 1981 | Substantially Equivalent | The Hilrad Co. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.