510(k) · Cleared
ClearedAmsco Warming Cabinet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Dec 18, 2009 as substantially equivalent to K993797 (Enthermics Medical Systems, Inc., 2000) after a 95-day review. Its family tree reaches back 1 generation to 2000. 6 later devices descend from it.
- Decided
- Dec 18, 2009
- Review
- 95 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993797 (2000). 6 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK993797 EC-7701 Fluid Warming CabinetEnthermics Medical Systems, Inc. · 2000
- This deviceK092823 Amsco Warming CabinetSTERIS Corporation · 2009
- Descendant · cites it directly · 2 of its ownK112702 Imperial Surgical LTD. Blankey and Solution Warning CabinetsImperial Surgical, Ltd. · 2012
- Descendant · 2 generations on · 0 of its ownK180842 MAC Medical D-Series Blanket and Solution Warming CabinetsMac Medical, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK153713 Getinge Series Warming CabinetGetinge Sourcing, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK132110 Natus Warmette Blanket and Dual CabinetsNatus Nicolet Ireland, Ltd. · 2013 · Recalled
- Descendant · cites it directly · 0 of its ownK111870 Amsco Warming CabinetSTERIS Corporation · 2011 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K112702Imperial Surgical LTD. Blankey and Solution Warning CabinetsImperial Surgical, Ltd. · 2012 · cites it directly2descendants
- K180842MAC Medical D-Series Blanket and Solution Warming CabinetsMac Medical, Inc. · 2019 · 2 generations on0descendants
- K153713Getinge Series Warming CabinetGetinge Sourcing, LLC · 2016 · cites it directly0descendants
- K132110Natus Warmette Blanket and Dual CabinetsNatus Nicolet Ireland, Ltd. · 2013 · 2 generations on0descendants
- K111870Amsco Warming CabinetSTERIS Corporation · 2011 · cites it directly0descendants
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) | K092823 | Amsco Warming Cabinet | STERIS Corporation | 2009 | — |
| +1 | K112702 | Imperial Surgical LTD. Blankey and Solution Warning Cabinets | Imperial Surgical, Ltd. | 2012 | — |
| +2 | K180842 | MAC Medical D-Series Blanket and Solution Warming Cabinets | Mac Medical, Inc. | 2019 | — |
| +1 | K153713 | Getinge Series Warming Cabinet | Getinge Sourcing, LLC | 2016 | — |
| +2 | K132110 | Natus Warmette Blanket and Dual Cabinets | Natus Nicolet Ireland, Ltd. | 2013 | 1 |
| +1 | K111870 | Amsco Warming Cabinet | STERIS Corporation | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K993797 | EC-7701 Fluid Warming CabinetSummary page 5…ification Name; Warmer, Irrigation Solution Warmer, Cabinet 2. Predicate Device STERIS Amsco Warming Cabinet (Pre-Amendment) Enthermics EC-7701 Fluid Warming Cabinet, K993797, January 20, 2000 3. Description of Device The Amsco Warming Cabinet is designed to store and warm sterile IV solutions, surgic… | 2000 |
| * | — | STERIS Amsco Warming Cabinet (Pre-Amendment) Named without a submission number |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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. 2009, 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 Amsco Warming Cabinet is designed to raise the temperature of blankets, linens and
sterile surgical irrigation solutions and IV solutions to an acceptable level for various
surgical, obstetrical, emergency, critical care and other healthcare applications
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/K092823 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092823: Amsco Warming Cabinet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092823
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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