# K973741: Bair Hugger Blood/Fluid Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Augustine Medical, Inc.
- Decided: Apr 30, 1998 after 211 days
- Product code: BSB (Warmer, Blood, Non-Electromagnetic Radiation)
- Device class: 2
- Regulation: 21 CFR 864.9205
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 7 cite it directly.
4 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K950038: Dupaco Counterflo 300 Blood/Fluid Warmer. The summary prints BK950038, a CBER number, which our reading took as K950038, which is not in FDA’s 510(k) list. Kept off the family tree. Summary page 2.
- K940032: Bair Hugger 241 Fluid Warming Set. The summary prints BK940032, a CBER number, which our reading took as K940032, which is not in FDA’s 510(k) list. Kept off the family tree. Summary page 2.

## Most influential descendants
- K984640: Thermal Angel (1999), 16 descendants of its own
- K012031: Modification to Thermal Angel (2001), 13 descendants of its own
- K060537: Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC Power Supply, Model 120 (2006), 12 descendants of its own
- K112902: Enflow IV Fluid Warmer (2012), 10 descendants of its own
- K060939: Ranger Irrigation Fluid Warming System (2006), 8 descendants of its own

## Recalls of this device
- Apr 10, 2025 · Class I · Z-2483-2025: Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High Flow Sets.
- Jun 26, 2007 · Not classified · Z-1184-2007: Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed.
- Jun 26, 2007 · Not classified · Z-1183-2007: Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed.

## Indications for use
The Bair Hugger Blood/Fluid Warmer is intended to warm blood, blood products, and liquids.

Source page: https://510kreport.com/device/K973741
Methodology: https://510kreport.com/methodology