BAIR HUGGER BLOOD/FLUID WARMER
FDA 510(k) clearance K973741 · decided 1998-04-30
Clearance details
- K-number
- K973741
- Device name
- BAIR HUGGER BLOOD/FLUID WARMER
- Applicant
- Augustine Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-01
- Decision date
- 1998-04-30
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- BSB
- Device class
- 2
- Regulation number
- 864.9205
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| THERMACYL BLOOD/FLUID WARMER (K953741) | Baxter Healthcare Corp | 1996-06-26 |
| BLOOD/FLUID WARMER MODEL DW-1000A (K770232) | Gorman Rupp Industries | 1977-02-14 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370 recall (Z-2483-2025) | 3M Company | 2025-09-18 |
| Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection recall (Z-1183-2007) | Arizant Healthcare, Inc | 2007-08-18 |
| Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection recall (Z-1184-2007) | Arizant Healthcare, Inc | 2007-08-18 |