510(k) · Cleared
Recalled · Class II · 2014Thermal 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 1, 1999 as substantially equivalent to K973741 (Augustine Medical, Inc., 1998) and 2 other predicates after a 182-day review. Its family tree reaches back 1 generation to 1977. 3 of the 20 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it. It has been recalled once.
- Decided
- Jul 1, 1999
- Review
- 182 days
- Class
- Class II
- Product code
- BSB
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K770232 (1977). 3 ancestors in all. 16 later devices descend from it, 2 citing it directly. 3 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK770232 Blood/Fluid Warmer Model DW-1000AGorman Rupp Industries · 1977
- This deviceK984640 Thermal AngelEstill Medical Technologies, Inc. · 1999
- 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 · 4 generations on · 1 of its ownK232107 °M Warmer SystemMequ A/S · 2024
- Descendant · 4 generations on · 1 of its ownK211618 Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V. · 2023
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 16 · See all- 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
- K232107°M Warmer SystemMequ A/S · 2024 · 4 generations on1descendant
- K211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V. · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K770232 | Blood/Fluid Warmer Model DW-1000A | Gorman Rupp Industries | 1977 | — |
| 0 (this device) | K984640 | Thermal Angel | Estill Medical Technologies, Inc. | 1999 | — |
| +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 | — |
| +4 | K232107 | °M Warmer System | Mequ A/S | 2024 | — |
| +4 | K211618 | Fluido Compact Blood and Fluid Warming System | The Surgical Company International B.V. | 2023 | — |
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 |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 2 | 1 |
| 2011 | 1 | 0 |
| 2012 | 3 | 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? (3)
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…he New Device and the Predicate Devices: The Themmal Angel™ 200 Blood/Fluid Warmer is substantially equivalent to the Augustine Medical Bair Hugger™ Blood/Fiuid Warmer (K973741), the Baxter Themacyl™ Blood/Fiuid Warmer (K770232) and the Level 1 Technologies, Inc. Hotline™ Fluid Wamer (K911383). A comparis… | 1998 |
| * | K770232 | Blood/Fluid Warmer Model DW-1000ASummary page 2…al Angel™ 200 Blood/Fluid Warmer is substantially equivalent to the Augustine Medical Bair Hugger™ Blood/Fiuid Warmer (K973741), the Baxter Themacyl™ Blood/Fiuid Warmer (K770232) and the Level 1 Technologies, Inc. Hotline™ Fluid Wamer (K911383). A comparison of technological features are on the following p… | 1977 |
| * | K911383 | Hotline Fluid WarmerSummary page 2…e Augustine Medical Bair Hugger™ Blood/Fiuid Warmer (K973741), the Baxter Themacyl™ Blood/Fiuid Warmer (K770232) and the Level 1 Technologies, Inc. Hotline™ Fluid Wamer (K911383). A comparison of technological features are on the following page. Discussion of Nonclinical Studies: Studies will be conducte… | 1991 |
What descends from it? (16)
See all 162 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 · 2 generations on · ◆ in the 2006 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?
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™ is an in-line intravenous fluid and blood warmer. Thermal Angel™ is indicated for use whenever parenteral introduction of normothermic 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/K984640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984640: 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/K984640
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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