510(k) · Cleared
ClearedThermacyl Blood/Fluid Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · BSB Warmer, Blood, Non-Electromagnetic Radiation
Cleared on Jun 26, 1996 as substantially equivalent to K770232 (Gorman Rupp Industries, 1977) after a 321-day review. Its family tree reaches back 1 generation to 1977.
- Decided
- Jun 26, 1996
- Review
- 321 days
- Class
- Class II
- Product code
- BSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K770232 (1977). No later device cites it as a predicate yet.
- Root · 1 generation backK770232 Blood/Fluid Warmer Model DW-1000AGorman Rupp Industries · 1977
- This deviceK953741 Thermacyl Blood/Fluid WarmerBaxter Healthcare Corp · 1996
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) | K953741 | Thermacyl Blood/Fluid Warmer | Baxter Healthcare Corp | 1996 | — |
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.
Planning a device in BSB? 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 |
|---|---|---|---|
| * | K770232 | Blood/Fluid Warmer Model DW-1000ASummary page 2…evice and the Predicate Devices The ThermaCyl™ blood/fluid warmer is substantially equivalent to the Pharmaseal blood/fluid warmer (found substantially equivalent under K770232) and the Alton Dean blood/fluid warmer (found substantially equivalent under BK910033). A comparison of technological features f… | 1977 |
| Kept off the family tree | K910033 | FDA’s K910033 is Ubi Magiwel (TM) Ana Quantitative The summary prints BK910033, a CBER number, which our reading took as K910033, FDA’s number for Ubi Magiwel (TM) Ana Quantitative (United Biotech, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Alton Dean blood/fluid warmer”. Kept off the family tree. Summary page 2…ivalent to the Pharmaseal blood/fluid warmer (found substantially equivalent under K770232) and the Alton Dean blood/fluid warmer (found substantially equivalent under BK910033). A comparison of technological features follows: ALTON DEAN BAXTER THERMACYL™ PHARMASEAL" FEATURE BLOOD WARMER BLOOD/FLUID WARM… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K770232.
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 ThermaCyl™ blood/fluid warmer is indicated for the warming of blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in clinical environments.
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/K953741 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953741: Thermacyl 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/K953741
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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