510(k) · Cleared
Cleared°M Warmer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mequ A/S · LGZ Warmer, Thermal, Infusion Fluid
Cleared on May 31, 2024 as substantially equivalent to K112902 (Vital Signs, Inc., 2012) after a 322-day review. Its family tree reaches back 5 generations to 1977. 2 of the 9 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- May 31, 2024
- Review
- 322 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K770232 (1977). 7 ancestors in all. 1 later device descends from it, 1 citing it directly. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK770232 Blood/Fluid Warmer Model DW-1000AGorman Rupp Industries · 1977
- 4 generations backK984640 Thermal AngelEstill Medical Technologies, Inc. · 1999 · Recalled
- 3 generations backK012031 Modification to Thermal AngelEstill Medical Technologies, Inc. · 2001 · Recalled
- 2 generations backK060537 Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model…Enginivity, LLC · 2006 · Recalled (Class I)
- 1 generation backK112902 Enflow IV Fluid WarmerVital Signs, Inc. · 2012
- This deviceK232107 °M Warmer SystemMequ A/S · 2024
- Descendant · cites it directly · 0 of its ownK260988 °M Warmer System with °M StationMequ A/S · 2026
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K260988°M Warmer System with °M StationMequ A/S · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K770232 | Blood/Fluid Warmer Model DW-1000A | Gorman Rupp Industries | 1977 | — |
| −4 | K984640 | Thermal Angel | Estill Medical Technologies, Inc. | 1999 | 1 |
| −3 | 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 |
| −1 | K112902 | Enflow IV Fluid Warmer | Vital Signs, Inc. | 2012 | — |
| 0 (this device) | K232107 | °M Warmer System | Mequ A/S | 2024 | — |
| +1 | K260988 | °M Warmer System with °M Station | Mequ A/S | 2026 | — |
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 |
|---|---|---|
| 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.
2 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.
Top candidate predicates for a new LGZ device
- #1 K260988 °M Warmer System with °M Stationscore 12.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K112902 | Enflow IV Fluid WarmerSummary page 5…ubstantial equivalence is claimed to: enFlow IV Fluid Warmer (K112902) Indications for use… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260988 | °M Warmer System with °M Station | 2026 | 0 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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 back · ◆ on the line of descent in FIG. 12 Class I recalls
- K973741Bair Hugger Blood/Fluid WarmerAugustine Medical, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 47 years and passes through 5 companies; a new generation was cleared every 5.8 years on median.
- 5 of the 7 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K260988 (Mequ A/S, 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K112902.
How does its category compare?
All LGZ devicesLGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · LGZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LGZ
546in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LGZ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LGZ
376in 2025
MAUDE reports naming product code LGZ, 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 | 2 | — | 0 | 11 |
| 2008 | 4 | 99 | 0 | 10 |
| 2009 | 2 | — | 1 | 12 |
| 2010 | 2 | — | 1 | 43 |
| 2011 | 3 | 77 | 8 | 54 |
| 2012 | 7 | 162 | 0 | 52 |
| 2013 | 5 | 143 | 0 | 16 |
| 2014 | 0 | — | 0 | 23 |
| 2015 | 2 | — | 1 | 34 |
| 2016 | 2 | — | 1 | 15 |
| 2017 | 2 | — | 0 | 58 |
| 2018 | 1 | — | 0 | 94 |
| 2019 | 3 | 209 | 0 | 340 |
| 2020 | 0 | — | 0 | 1,221 |
| 2021 | 0 | — | 0 | 885 |
| 2022 | 3 | 546 | 0 | 1,548 |
| 2023 | 1 | — | 0 | 1,033 |
| 2024 | 1 | — | 0 | 862 |
| 2025 | 2 | — | 0 | 376 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232107 · printed Nov 3, 2026
Cite this page
510(k) Report. “K232107: °M Warmer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K232107
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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