510(k) · Cleared
Cleared°M Warmer System with °M Station
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 Apr 24, 2026 as substantially equivalent to K232107 (Mequ A/S, 2024) after a 30-day review. Its family tree reaches back 6 generations to 1977. 2 of the 9 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 24, 2026
- Review
- 30 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K770232 (1977). 8 ancestors in all. No later device cites it as a predicate yet. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK770232 Blood/Fluid Warmer Model DW-1000AGorman Rupp Industries · 1977
- 5 generations backK984640 Thermal AngelEstill Medical Technologies, Inc. · 1999 · Recalled
- 4 generations backK012031 Modification to Thermal AngelEstill Medical Technologies, Inc. · 2001 · Recalled
- 3 generations backK060537 Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model…Enginivity, LLC · 2006 · Recalled (Class I)
- 2 generations backK112902 Enflow IV Fluid WarmerVital Signs, Inc. · 2012
- 1 generation backK232107 °M Warmer SystemMequ A/S · 2024
- This deviceK260988 °M Warmer System with °M StationMequ A/S · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K770232 | Blood/Fluid Warmer Model DW-1000A | Gorman Rupp Industries | 1977 | — |
| −5 | K984640 | Thermal Angel | Estill Medical Technologies, Inc. | 1999 | 1 |
| −4 | K012031 | Modification to Thermal Angel | Estill Medical Technologies, Inc. | 2001 | 1 |
| −3 | 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 | — |
| −1 | K232107 | °M Warmer System | Mequ A/S | 2024 | — |
| 0 (this device) | 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 |
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 K262532 NORMOFLO™ Irrigation Fluid Warming Sets and…score 12.6 · 3 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 |
|---|---|---|---|
| * | K232107 | °M Warmer SystemSummary page 5…, Non-Electromagnetic Radiation (21 CFR, 864.9205, product code BSB) Substantial equivalence is claimed to: °M Warmer System (K232107) Page 1 of 5 Purpose of 510… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K973741Bair Hugger Blood/Fluid WarmerAugustine Medical, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 49 years and passes through 5 companies; a new generation was cleared every 5.8 years on median.
- 5 of the 8 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All LGZ devicesLGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 with °M Station 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 ambulances.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260988: °M Warmer System with °M Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260988
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026