510(k) · Cleared
ClearedEnteral Nutrition Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acacia, Inc. · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Jun 13, 2013 as substantially equivalent to K024373 (Elltec Co., Ltd., 2003) after a 304-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.
- Decided
- Jun 13, 2013
- Review
- 304 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K024373 (2003). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K150484Penguin In-Line WarmerCreche Innovations · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K024373 | Modification to Animec, Models AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5 | Elltec Co., Ltd. | 2003 | — |
| 0 (this device) | K122449 | Enteral Nutrition Warmer | Acacia, Inc. | 2013 | — |
| +1 | K150484 | Penguin In-Line Warmer | Creche Innovations | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (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 |
|---|---|---|---|
| * | K024373 | Modification to Animec, Models AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5Summary page 1…n Fluid CLASSIFICATION NAME: Warmer, Thermal, Infusion Fluid DEevICE CLASSIFICATION: Unclassified ProbucT CODE LGZ PREDICATE DEVICES: Elitec Enterat Nutrition Warmer (K024373) Purpose The purpose of this submission is to introduce a new device for Enteral Nutrition Warming. Substantially Equivalent To… | 2003 |
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 |
|---|---|---|---|
| K150484 | Penguin In-Line Warmer | 2015 | 0 |
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?
How does its category compare?
All LGZ devicesLGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Enteral Nutrition Warmer is an electronically powered dry warmer, which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate applications at 0 to 7mL/min.
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/K122449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122449: Enteral Nutrition Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122449
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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