FOH
6 FDA 510(k) clearances · Product code
21 daysmedian time to decision
93 days90th percentile
6clearances measured
FDA profile
- Official device name
- Mattress, Water, Temperature Regulated
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5560
- Medical specialty
- General Hospital
- Adverse events (MAUDE)
- 1996: 1 · 1997: 1 · 2007: 2 · 2011: 9
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 |
|---|---|---|
| OLYMPIC WARM-BASSINET (K954216) | Olympic Medical Corp. | 1995-12-08 |
| IMSI/EASY FLOAT MATTRESS (K872876) | Intl. Management Services, Inc. | 1987-10-13 |
| NEONATE FLEXFLOAT (K812683) | Pharmaquest Corp. | 1981-10-13 |
| FLEXFLOAT HEATER (K812682) | Pharmaquest Corp. | 1981-10-08 |
| ADULT FLEX FLOAT W/HEATER (K812681) | Pharmaquest Corp. | 1981-10-08 |
| ADULT FLEXFLOAT (K812684) | Pharmaquest Corp. | 1981-10-08 |
Track FOH automatically
Every clearance here is in the API, with alerts when new ones post.