BSB
14 FDA 510(k) clearances · Product code
56 daysmedian time to decision
211 days90th percentile
14clearances measured
FDA profile
- Official device name
- Warmer, Blood, Non-Electromagnetic Radiation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9205
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 2021: 340 · 2022: 447 · 2023: 290 · 2024: 282 · 2025: 198 · 2026: 66
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 |
|---|---|---|
| THE BELMONT BUDDY LITE FLUID WARMER (K112639) | Belmont Instrument Corp. | 2011-11-16 |
| THE BELMONT BUDDY LITE FLUID WARMER (K090508) | Belmont Instrument Corp. | 2009-03-26 |
| BELMONT BUDDY PLUS FLUID WARMER (K062774) | Belmont Instrument Corp. | 2006-10-19 |
| BELMONT BUDDY FLUID WARMER (K052547) | Belmont Instrument Corp. | 2005-10-13 |
| MICROHEATER (K031478) | Belmont Instrument Corp. | 2003-07-02 |
| ASTOFLO (K020060) | Nats Corp. | 2002-03-05 |
| MODIFICATION TO THERMAL ANGEL (K012031) | Estill Medical Technologies, Inc. | 2001-07-26 |
| PRISMATHERM II, ASTOLINE (K991159) | Stihler Electronic GmbH | 1999-09-03 |
| ASTOTHERM PLUS, ASTOTUBES, ASTOLINE (K991160) | Stihler Electronic GmbH | 1999-09-02 |
| THERMAL ANGEL (K984640) | Estill Medical Technologies, Inc. | 1999-07-01 |
| BAIR HUGGER BLOOD/FLUID WARMER (K973741) | Augustine Medical, Inc. | 1998-04-30 |
| THERMACYL BLOOD/FLUID WARMER (K953741) | Baxter Healthcare Corp | 1996-06-26 |
| BLOOD/FLUID WARMER MODEL DW-1000A (K770232) | Gorman Rupp Industries | 1977-02-14 |
| BLOOD WARMER (CODE 4R4305) (K760012) | Travenol Laboratories, S.A. | 1976-07-16 |
Track BSB automatically
Every clearance here is in the API, with alerts when new ones post.