510(k) · Cleared
Recalled · Class II · 2016Natus Warmette Blanket and Dual Cabinets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Nicolet Ireland, Ltd. · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Oct 3, 2013 as substantially equivalent to K112702 (Imperial Surgical, Ltd., 2012) after an 86-day review. Its family tree reaches back 3 generations to 2000. It has been recalled once.
- Decided
- Oct 3, 2013
- Review
- 86 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K993797 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK993797 EC-7701 Fluid Warming CabinetEnthermics Medical Systems, Inc. · 2000
- 2 generations backK092823 Amsco Warming CabinetSTERIS Corporation · 2009
- 1 generation backK112702 Imperial Surgical LTD. Blankey and Solution Warning CabinetsImperial Surgical, Ltd. · 2012
- This deviceK132110 Natus Warmette Blanket and Dual CabinetsNatus Nicolet Ireland, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993797 | EC-7701 Fluid Warming Cabinet | Enthermics Medical Systems, Inc. | 2000 | — |
| −2 | K092823 | Amsco Warming Cabinet | STERIS Corporation | 2009 | — |
| −1 | K112702 | Imperial Surgical LTD. Blankey and Solution Warning Cabinets | Imperial Surgical, Ltd. | 2012 | — |
| 0 (this device) | K132110 | Natus Warmette Blanket and Dual Cabinets | Natus Nicolet Ireland, Ltd. | 2013 | — |
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 |
|---|---|---|---|
| * | K112702 | Imperial Surgical LTD. Blankey and Solution Warning CabinetsSummary page 1…tus Warmette® Dual Cabinet Common or Usual Name: Warming Cabinets Classification Name And Number: Unclassified, Product Code: LGZ Predicate Device: K1 12702 Imperial Surgical Blanket and Solution Warming Cabinets Device Description: The Natus Warmette® C… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 15, 2016 | Class II | Z-0951-2017 | Mixed-up of materials/components | The fuse blows during initial power up or after a period of time. This results in a complete loss of power to the Cabinet and in some cases has resulted in the fuse cover for the power inlet melting slightly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K112702.
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 Natus Warmette® Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette® Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132110: Natus Warmette Blanket and Dual Cabinets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132110
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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