LDSClass II
Device, Pasteurization, Hot Water
21 CFR 880.6991 / General Hospital
LDS is the FDA product code for Device, Pasteurization, Hot Water, a class II device type, regulated under 21 CFR 880.6991. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 11 recalls.
Classification record
- Product code
- LDS
- Device name
- Device, Pasteurization, Hot Water
- Regulation
- 21 CFR 880.6991
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 11
- Ingested recalls
- 11
Clearances, product code LDS
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1985 | 1 |
| 1986 | 1 |
| 1989 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 1 |
| 2000 | 1 |
| 2003 | 1 |
| 2019 | 1 |
Applicants with the most clearances
Product code LDS| Applicant | Clearances |
|---|---|
| Castle Co. | 2 |
| Olympic Medical Corp. | 2 |
| Cenorin, LLC | 1 |
| Getinge Disinfection AB | 1 |
| Miele Appliances, Inc. | 1 |
| Miele Professional | 1 |
| Miele Inc. | 1 |
| STERIS Corporation | 1 |
| The Hilrad Co. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
