LDS
11 FDA 510(k) clearances · Product code
155 daysmedian time to decision
354 days90th percentile
11clearances measured
FDA profile
- Official device name
- Device, Pasteurization, Hot Water
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6991
- Medical specialty
- General Hospital
- Adverse events (MAUDE)
- 1994: 1 · 2011: 14 · 2012: 63 · 2013: 10
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector (K183444) | Cenorin, LLC | 2019-09-09 |
| MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 (K031799) | Miele, Inc. | 2003-11-12 |
| RELIANCE FAMILY OF WASHER-DISINFECTORS (K983068) | STERIS Corporation | 2000-05-31 |
| OLYMPIX MINI-PASTEURMATIC (58210) (K972193) | Olympic Medical Corp. | 1997-09-05 |
| MIELE G 7781 DENTAL THERMAL DISINFECTOR (K950518) | Miele Professional | 1996-01-26 |
| DECOMAT 4656 (K950566) | Getinge Disinfection, Inc. | 1995-10-19 |
| OLYMPIC PASTEURMATIC SYSTEM (K953645) | Olympic Medical Corp. | 1995-09-22 |
| MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU. (K884151) | Miele Appliances, Inc. | 1989-05-16 |
| CASTLE 7538 FLOOR LOADING WASHER (K860263) | Castle Co. | 1986-03-05 |
| CASTLE 7515 UTENSIL/GLASSWARE WASHER (K844089) | Castle Co. | 1985-01-14 |
| STERI-VERS (K810311) | The Hilrad Co. | 1981-04-17 |
Track LDS automatically
Every clearance here is in the API, with alerts when new ones post.