510(k) · Cleared
ClearedEnflow IV Fluid Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Signs, Inc. · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Mar 14, 2012 as substantially equivalent to K060537 (Enginivity, LLC, 2006) after a 162-day review. Its family tree reaches back 4 generations to 1977. 3 of the 17 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it.
- Decided
- Mar 14, 2012
- Review
- 162 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K770232 (1977). 6 ancestors in all. 10 later devices descend from it, 5 citing it directly. 3 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK770232 Blood/Fluid Warmer Model DW-1000AGorman Rupp Industries · 1977
- 3 generations backK984640 Thermal AngelEstill Medical Technologies, Inc. · 1999 · Recalled
- 2 generations backK012031 Modification to Thermal AngelEstill Medical Technologies, Inc. · 2001 · Recalled
- 1 generation backK060537 Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model…Enginivity, LLC · 2006 · Recalled (Class I)
- This deviceK112902 Enflow IV Fluid WarmerVital Signs, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK232107 °M Warmer SystemMequ A/S · 2024
- Descendant · cites it directly · 1 of its ownK211618 Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V. · 2023
- Descendant · cites it directly · 1 of its ownK181775 Quantum Blood and IV Fluid Infusion WarmerLife Warmer, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK150404 QiF Blood and Fluid WarmerQuality IN Flow, Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK121775 Enflow IV Fluid Warmer, Enflow Disposable Cartridge, Enflow ControllerVital Signs, Inc., A GE Healthcare Company · 2012
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- K232107°M Warmer SystemMequ A/S · 2024 · cites it directly1descendant
- K211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V. · 2023 · cites it directly1descendant
- K181775Quantum Blood and IV Fluid Infusion WarmerLife Warmer, Inc. · 2019 · cites it directly1descendant
- K150404QiF Blood and Fluid WarmerQuality IN Flow, Ltd. · 2016 · cites it directly1descendant
- K121775Enflow IV Fluid Warmer, Enflow Disposable Cartridge, Enflow ControllerVital Signs, Inc., A GE Healthcare Company · 2012 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K770232 | Blood/Fluid Warmer Model DW-1000A | Gorman Rupp Industries | 1977 | — |
| −3 | K984640 | Thermal Angel | Estill Medical Technologies, Inc. | 1999 | 1 |
| −2 | K012031 | Modification to Thermal Angel | Estill Medical Technologies, Inc. | 2001 | 1 |
| −1 | K060537 | Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and… | Enginivity, LLC | 2006 | Class I |
| 0 (this device) | K112902 | Enflow IV Fluid Warmer | Vital Signs, Inc. | 2012 | — |
| +1 | K232107 | °M Warmer System | Mequ A/S | 2024 | — |
| +1 | K211618 | Fluido Compact Blood and Fluid Warming System | The Surgical Company International B.V. | 2023 | — |
| +1 | K181775 | Quantum Blood and IV Fluid Infusion Warmer | Life Warmer, Inc. | 2019 | — |
| +1 | K150404 | QiF Blood and Fluid Warmer | Quality IN Flow, Ltd. | 2016 | — |
| +1 | K121775 | Enflow IV Fluid Warmer, Enflow Disposable Cartridge, Enflow Controller | Vital Signs, Inc., A GE Healthcare Company | 2012 | — |
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 |
|---|---|---|
| 2012 | 1 | 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.
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 |
|---|---|---|---|
| * | K060537 | Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC…Summary page 1…s HI 4. Legally Marketed Predicate Device: Substantial equivalence is claimed to: Enginivity / Vital Signs eFlow Model 100 IV Fluid Warmer (K060537) enFlow IV Fluid Warmer… | 2006 |
What descends from it? (10)
5 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)
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 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K973741Bair Hugger Blood/Fluid WarmerAugustine Medical, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K130867Enflow IV Fluid Warmer Insulated StrapVital Signs, Inc., A GE Healthcare Company · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 35 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 5 of the 6 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K232107 (Mequ A/S, 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K060537.
How does its category compare?
All LGZ devicesLGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 enFlow IV Fluid Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112902 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112902: Enflow IV 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/K112902
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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