510(k) · Cleared
Recalled · Class I · 2019Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC Power Supply, Model 120
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enginivity, LLC · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Jun 8, 2006 as substantially equivalent to K012031 (Estill Medical Technologies, Inc., 2001) after a 100-day review. Its family tree reaches back 3 generations to 1977. 3 of the 18 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it. It has been recalled 6 times, including 2 Class I recalls.
- Decided
- Jun 8, 2006
- Review
- 100 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- 6 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 3 generations to K770232 (1977). 5 ancestors in all. 12 later devices descend from it, 2 citing it directly. 3 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK770232 Blood/Fluid Warmer Model DW-1000AGorman Rupp Industries · 1977
- 2 generations backK984640 Thermal AngelEstill Medical Technologies, Inc. · 1999 · Recalled
- 1 generation backK012031 Modification to Thermal AngelEstill Medical Technologies, Inc. · 2001 · Recalled
- This deviceK060537 Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model…Enginivity, LLC · 2006
- Descendant · cites it directly · 10 of its ownK112902 Enflow IV Fluid WarmerVital Signs, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK232107 °M Warmer SystemMequ A/S · 2024
- Descendant · 2 generations on · 1 of its ownK211618 Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V. · 2023
- Descendant · 2 generations on · 1 of its ownK181775 Quantum Blood and IV Fluid Infusion WarmerLife Warmer, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK150404 QiF Blood and Fluid WarmerQuality IN Flow, Ltd. · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 12 · See all- K112902Enflow IV Fluid WarmerVital Signs, Inc. · 2012 · cites it directly10descendants
- K232107°M Warmer SystemMequ A/S · 2024 · 2 generations on1descendant
- K211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V. · 2023 · 2 generations on1descendant
- K181775Quantum Blood and IV Fluid Infusion WarmerLife Warmer, Inc. · 2019 · 2 generations on1descendant
- K150404QiF Blood and Fluid WarmerQuality IN Flow, Ltd. · 2016 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K770232 | Blood/Fluid Warmer Model DW-1000A | Gorman Rupp Industries | 1977 | — |
| −2 | K984640 | Thermal Angel | Estill Medical Technologies, Inc. | 1999 | 1 |
| −1 | K012031 | Modification to Thermal Angel | Estill Medical Technologies, Inc. | 2001 | 1 |
| 0 (this device) | K060537 | Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and… | Enginivity, LLC | 2006 | — |
| +1 | K112902 | Enflow IV Fluid Warmer | Vital Signs, Inc. | 2012 | — |
| +2 | K232107 | °M Warmer System | Mequ A/S | 2024 | — |
| +2 | K211618 | Fluido Compact Blood and Fluid Warming System | The Surgical Company International B.V. | 2023 | — |
| +2 | K181775 | Quantum Blood and IV Fluid Infusion Warmer | Life Warmer, Inc. | 2019 | — |
| +2 | K150404 | QiF Blood and Fluid Warmer | Quality IN Flow, Ltd. | 2016 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 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 |
|---|---|---|---|
| * | K012031 | Modification to Thermal AngelSummary page 4…classified 4. Legally Marketed Equivalent Device Names: Substantial equivalence is claimed to Estill Medical Technologies® Thermal Angel, Model 200 cfeared under 510(k) K012031 on July 26, 2001. 5. Performance Standards: ASTM F 2172-02 Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid… | 2001 |
What descends from it? (12)
See all 122 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 |
|---|---|---|---|---|
| Mar 13, 2019 | Class I | Z-1385-2019 | Device Design | Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming. |
| Mar 13, 2019 | Class I | Z-1386-2019 | Device Design | Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming. |
| Feb 20, 2012 | Class II | Z-1972-2012 | Device Design | The EnFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 10993) for products that may have contact with skin for less than 24 hours. |
| Jun 30, 2011 | Not classified | Z-3040-2011 | Device Design | enFlow IV Fluid Warmer may have an issue which results in excessive external surface temperature on the underside of the warmer. |
| Jul 15, 2010 | Not classified | Z-2380-2010 | Equipment maintenance | The enFlow Disposable IV Fluid/Blood Warmer Cartridge's male luer-lock fitting may be oversized and may not fit properly with standard female luer fittings. |
| Mar 23, 2009 | Not classified | Z-2008-2009 | Device Design | 1. Fluid contamination of the electronic circuitry can cause short circuits resulting in permanent fuse failure or localized circuit board overheating with possible smoldering and discoloration. 2. Electromagnetic (EMI) Interference… |
The 5 latest of 6 recalls; the web page lists all.
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 · 2 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 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 4 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K112902 (Vital Signs, Inc., 2012) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K012031.
How does its category compare?
All LGZ devicesLGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 eFlow 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K060537 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060537: Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC Power Supply, Model 120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060537
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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