510(k) · Cleared
ClearedIvnow Modular Fluid Warmer, 120V, Model Ivnow-1, Ivnow-2, Ivnow-3, Ivnow-6, Ivnow Modular Fluid Warmer 230V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enthermics Medical Systems, Inc. · LGZ Warmer, Thermal, Infusion Fluid
Cleared on May 7, 2010 as substantially equivalent to K012276 (Medical Solutions, Inc., 2001) and 1 other predicate after a 366-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- May 7, 2010
- Review
- 366 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K993797 (2000). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK993797 EC-7701 Fluid Warming CabinetEnthermics Medical Systems, Inc. · 2000
- This deviceK091336 Ivnow Modular Fluid Warmer, 120V, Model Ivnow-1, Ivnow-2, Ivnow-3…Enthermics Medical Systems, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993797 | EC-7701 Fluid Warming Cabinet | Enthermics Medical Systems, Inc. | 2000 | — |
| 0 (this device) | K091336 | Ivnow Modular Fluid Warmer, 120V, Model Ivnow-1, Ivnow-2, Ivnow-3, Ivnow-6… | Enthermics Medical Systems, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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.
Planning a device in LGZ? 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012276 | TEMP 3Summary page 1…tal No performance standards have been officialfy adopted by FDA. 2131400 D. Devices to Which the New Device is Substantially Equivalent: TEMP 3 Fluid Warming System (K012276) EC-7701 Fluid Warming Cabinet (K993797) DC-1255287 v} IL IIL DEVICE DESCRIPTION: Enthermics Medical Systems’… | 2001 |
| * | K993797 | EC-7701 Fluid Warming CabinetSummary page 1…officialfy adopted by FDA. 2131400 D. Devices to Which the New Device is Substantially Equivalent: TEMP 3 Fluid Warming System (K012276) EC-7701 Fluid Warming Cabinet (K993797) DC-1255287 v} IL IIL DEVICE DESCRIPTION: Enthermics Medical Systems’ ivNow Modular Fluid Warmer is designed… | 2000 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K012276.
How does its category compare?
All LGZ devicesLGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 ivNow Modular Fluid Warmer is intended to warm injection / IV and irrigation fluid bags to a predetermined temperature, and once warm, to monitor and control the temperature of the fluid in the bags.
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/K091336 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091336: Ivnow Modular Fluid Warmer, 120V, Model Ivnow-1, Ivnow-2, Ivnow-3, Ivnow-6, Ivnow Modular Fluid Warmer 230V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091336
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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