510(k) · Cleared
Recalled · Class I · 2025Bair Hugger Blood/Fluid Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Augustine Medical, Inc. · BSB Warmer, Blood, Non-Electromagnetic Radiation
Cleared on Apr 30, 1998 after a 211-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below). 4 of the 32 devices in its family, counting itself, have a Class I recall. 31 later devices descend from it. It has been recalled 3 times, including a Class I recall.
- Decided
- Apr 30, 1998
- Review
- 211 days
- Class
- Class II
- Product code
- BSB
- Recalls
- 3 (1 Class I)
- Predicates
- 2
31 later devices descend from it, 7 citing it directly. 4 of the 32 devices in this family, counting this one, have a Class I recall.
- This deviceK973741 Bair Hugger Blood/Fluid WarmerAugustine Medical, Inc. · 1998
- Descendant · cites it directly · 16 of its ownK984640 Thermal AngelEstill Medical Technologies, Inc. · 1999 · Recalled
- Descendant · cites it directly · 13 of its ownK012031 Modification to Thermal AngelEstill Medical Technologies, Inc. · 2001 · Recalled
- Descendant · 2 generations on · 12 of its ownK060537 Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model…Enginivity, LLC · 2006 · Recalled (Class I)
- Descendant · 3 generations on · 10 of its ownK112902 Enflow IV Fluid WarmerVital Signs, Inc. · 2012
- Descendant · cites it directly · 8 of its ownK060939 Ranger Irrigation Fluid Warming SystemArizant Healthcare, Inc. · 2006 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 31 · See all- K984640Thermal AngelEstill Medical Technologies, Inc. · 1999 · cites it directly16descendants
- K012031Modification to Thermal AngelEstill Medical Technologies, Inc. · 2001 · cites it directly13descendants
- K060537Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC…Enginivity, LLC · 2006 · 2 generations on12descendants
- K112902Enflow IV Fluid WarmerVital Signs, Inc. · 2012 · 3 generations on10descendants
- K060939Ranger Irrigation Fluid Warming SystemArizant Healthcare, Inc. · 2006 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973741 | Bair Hugger Blood/Fluid Warmer | Augustine Medical, Inc. | 1998 | — |
| +1 | K984640 | Thermal Angel | Estill Medical Technologies, Inc. | 1999 | 1 |
| +1 | K012031 | Modification to Thermal Angel | Estill Medical Technologies, Inc. | 2001 | 1 |
| +2 | K060537 | Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and… | Enginivity, LLC | 2006 | Class I |
| +3 | K112902 | Enflow IV Fluid Warmer | Vital Signs, Inc. | 2012 | — |
| +1 | K060939 | Ranger Irrigation Fluid Warming System | Arizant Healthcare, Inc. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2006 | 3 | 1 |
| 2007 | 1 | 0 |
| 2008 | 2 | 1 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 1 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| 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…haracteristics of the New Device and Predicate Devices The Bair Hugger® Blood/Fluid Warmer is substantially equivalent to the Dupaco Counterflo 300 Blood/Fluid Warmer (BK950038) and the Bair Hugger® 241 Fluid Warming Set (BK940032). Comparison of Technological Features Feature Bair Hugger Blood/Fluid Wa… | |
| Kept off the family tree | 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…The Bair Hugger® Blood/Fluid Warmer is substantially equivalent to the Dupaco Counterflo 300 Blood/Fluid Warmer (BK950038) and the Bair Hugger® 241 Fluid Warming Set (BK940032). Comparison of Technological Features Feature Bair Hugger Blood/Fluid Warmer Dupaco Counterflo 300 241 Fluid Warming Set Flow… |
What descends from it? (31)
See all 317 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K984640 | Thermal Angel | 1999 | 16 |
| K012031 | Modification to Thermal Angel | 2001 | 13 |
| K060939 | Ranger Irrigation Fluid Warming System | 2006 | 8 |
| K012832 | Comfortmate Fluid Warming System, Model # FW-200; Comfortmate Disporsable Disposable… | 2001 | 2 |
| K082217 | Ranger Rapid Flow Blood/Fluid Warming System | 2008 | 1 |
| K060851 | Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2 IV Warmer and the… | 2006 | 1 |
| K120860 | Infu Box Type 0412A | 2012 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 10, 2025 | Class I | Z-2483-2025 | Device Design | 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 | Other | 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 | Other | Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K060537Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC Power Supply, Model 120Enginivity, LLC · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 12 Class I recalls
- K072080Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, IR-40…Smiths Medical Asd, Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
- K130867Enflow IV Fluid Warmer Insulated StrapVital Signs, Inc., A GE Healthcare Company · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K984640 (Estill Medical Technologies, Inc., 1999) has gone furthest, with 16 descendants of its own.
How does its category compare?
All BSB devicesBSB Warmer, Blood, Non-Electromagnetic Radiation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BSB
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · BSB
Too few BSB 510(k)s in any year since 2007 to give a median.
Recalls per year · BSB
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BSB
197in 2025
MAUDE reports naming product code BSB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 4 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 1 | — | 0 | 35 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 1 | 10 |
| 2015 | 0 | — | 0 | 11 |
| 2016 | 0 | — | 0 | 66 |
| 2017 | 0 | — | 0 | 29 |
| 2018 | 0 | — | 0 | 36 |
| 2019 | 0 | — | 0 | 147 |
| 2020 | 0 | — | 0 | 216 |
| 2021 | 0 | — | 0 | 340 |
| 2022 | 0 | — | 0 | 447 |
| 2023 | 0 | — | 0 | 290 |
| 2024 | 0 | — | 0 | 282 |
| 2025 | 0 | — | 0 | 197 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Bair Hugger Blood/Fluid Warmer is intended to warm blood, blood products, and liquids.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973741 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973741: Bair Hugger Blood/Fluid Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973741
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026