510(k) · Cleared
Recalled · Class II · 2014Modification to Thermal Angel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Estill Medical Technologies, Inc. · BSB Warmer, Blood, Non-Electromagnetic Radiation
Cleared on Jul 26, 2001 as substantially equivalent to K973741 (Augustine Medical, Inc., 1998) and 3 other predicates after a 28-day review. Its family tree reaches back 2 generations to 1977. 3 of the 18 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled once.
- Decided
- Jul 26, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- BSB
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K770232 (1977). 4 ancestors in all. 13 later devices descend from it, 2 citing it directly. 3 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK770232 Blood/Fluid Warmer Model DW-1000AGorman Rupp Industries · 1977
- 1 generation backK984640 Thermal AngelEstill Medical Technologies, Inc. · 1999 · Recalled
- This deviceK012031 Modification to Thermal AngelEstill Medical Technologies, Inc. · 2001
- Descendant · cites it directly · 12 of its ownK060537 Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model…Enginivity, LLC · 2006 · Recalled (Class I)
- Descendant · 2 generations on · 10 of its ownK112902 Enflow IV Fluid WarmerVital Signs, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK232107 °M Warmer SystemMequ A/S · 2024
- Descendant · 3 generations on · 1 of its ownK211618 Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V. · 2023
- Descendant · 3 generations on · 1 of its ownK181775 Quantum Blood and IV Fluid Infusion WarmerLife Warmer, Inc. · 2019
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K060537Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC…Enginivity, LLC · 2006 · cites it directly12descendants
- K112902Enflow IV Fluid WarmerVital Signs, Inc. · 2012 · 2 generations on10descendants
- K232107°M Warmer SystemMequ A/S · 2024 · 3 generations on1descendant
- K211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V. · 2023 · 3 generations on1descendant
- K181775Quantum Blood and IV Fluid Infusion WarmerLife Warmer, Inc. · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K770232 | Blood/Fluid Warmer Model DW-1000A | Gorman Rupp Industries | 1977 | — |
| −1 | K984640 | Thermal Angel | Estill Medical Technologies, Inc. | 1999 | 1 |
| 0 (this device) | K012031 | Modification to Thermal Angel | Estill Medical Technologies, Inc. | 2001 | — |
| +1 | K060537 | Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and… | Enginivity, LLC | 2006 | Class I |
| +2 | K112902 | Enflow IV Fluid Warmer | Vital Signs, Inc. | 2012 | — |
| +3 | K232107 | °M Warmer System | Mequ A/S | 2024 | — |
| +3 | K211618 | Fluido Compact Blood and Fluid Warming System | The Surgical Company International B.V. | 2023 | — |
| +3 | K181775 | Quantum Blood and IV Fluid Infusion Warmer | Life Warmer, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 1 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 1 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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.
3 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? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K973741 | Bair Hugger Blood/Fluid WarmerSummary page 2…Device and the Predigate Devices: The Thermal Angel™ model 200 Blood/Fiuid Warmar is substantially equivalent tc the Augustine Medical Bair Hugger ™ Blood/Fluld Warmer (K973741), the Baxter Thermacyl™ Blood/Fluid Warmer (K770232), the Levell Technologies, inc Hotline™ Fluid Warmer (K911383) and the Therma… | 1998 |
| * | K770232 | Blood/Fluid Warmer Model DW-1000ASummary page 2…™ model 200 Blood/Fiuid Warmar is substantially equivalent tc the Augustine Medical Bair Hugger ™ Blood/Fluld Warmer (K973741), the Baxter Thermacyl™ Blood/Fluid Warmer (K770232), the Levell Technologies, inc Hotline™ Fluid Warmer (K911383) and the Thermal Angel™ (K984640). Comparisons of technological fea… | 1977 |
| * | K911383 | Hotline Fluid WarmerSummary page 2…the Augustine Medical Bair Hugger ™ Blood/Fluld Warmer (K973741), the Baxter Thermacyl™ Blood/Fluid Warmer (K770232), the Levell Technologies, inc Hotline™ Fluid Warmer (K911383) and the Thermal Angel™ (K984640). Comparisons of technological features are on the following page. Discussion of Nonclinical St… | 1991 |
| * | K984640 | Thermal AngelSummary page 1…dicate Devices: Augustine Medical Bair Hugger™ Blood/Fluid Warmer, Levell Technologies, Inc Hotline™ Fluid Warmer, Baxter Thermacyl™ Blood/Fluid Warmer, Thermal Angei™ (K984640) Descriptiopn of Device: The Thermal Angel™ model 200 Blood/Fluid Warmer consists of a single unit that is placed between a sta… | 1999 |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 25, 2014 | Class II | Z-0101-2015 | Device Design | Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its capacity during a 60 minute charging period. If you have a fully discharged Ultra Battery 1 (TA-UB1), in order to achieve a 100% of charge… |
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.
- K973741Bair Hugger Blood/Fluid WarmerAugustine Medical, Inc. · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K060537Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC Power Supply, Model 120Enginivity, LLC · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 12 Class I recalls
- K130867Enflow IV Fluid Warmer Insulated StrapVital Signs, Inc., A GE Healthcare Company · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 22.4 years on median.
- 3 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K060537 (Enginivity, LLC, 2006) has gone furthest, with 12 descendants of its own.
- 6 other devices also cite its predicate K973741.
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?
Thermal Angel™ model 200 Blood and Fluid Warmer is an in-line, intravenous blood and fluid warmer. Thermal Angel™ is indicated for use whenever introduction of normothermic, parenteral (intravenous or irrigation) fluids are desired or indicated, whether in field or clinical settings.
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/K012031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012031: Modification to Thermal Angel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012031
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026