510(k) · Cleared
ClearedImperial Surgical LTD. Blankey and Solution Warning Cabinets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imperial Surgical, Ltd. · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Mar 29, 2012 as substantially equivalent to K092823 (STERIS Corporation, 2009) and 1 other predicate after a 195-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Mar 29, 2012
- Review
- 195 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K993797 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK993797 EC-7701 Fluid Warming CabinetEnthermics Medical Systems, Inc. · 2000
- 1 generation backK092823 Amsco Warming CabinetSTERIS Corporation · 2009
- This deviceK112702 Imperial Surgical LTD. Blankey and Solution Warning CabinetsImperial Surgical, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK180842 MAC Medical D-Series Blanket and Solution Warming CabinetsMac Medical, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK132110 Natus Warmette Blanket and Dual CabinetsNatus Nicolet Ireland, Ltd. · 2013 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993797 | EC-7701 Fluid Warming Cabinet | Enthermics Medical Systems, Inc. | 2000 | — |
| −1 | K092823 | Amsco Warming Cabinet | STERIS Corporation | 2009 | — |
| 0 (this device) | K112702 | Imperial Surgical LTD. Blankey and Solution Warning Cabinets | Imperial Surgical, Ltd. | 2012 | — |
| +1 | K180842 | MAC Medical D-Series Blanket and Solution Warming Cabinets | Mac Medical, Inc. | 2019 | — |
| +1 | K132110 | Natus Warmette Blanket and Dual Cabinets | Natus Nicolet Ireland, Ltd. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K092823 | Amsco Warming CabinetSummary page 4…Imperial Surgical Ltd. Amsco Warming Cabinet EC-7701 Fluid Warming Blanket and Solution (K092823) Cabinet (K993797) Warming Cabinets Door… | 2009 |
| * | K993797 | EC-7701 Fluid Warming CabinetSummary page 3…rming Cabinet EC-7701 Fluid Warming Blanket and Solution (1(092823) Cabinet (K993797) Warming Cabinets Intended Use The Imperial Surgical Ltd. Ainsc… | 2000 |
What descends from it? (2)
2 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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K180842 (Mac Medical, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K092823.
How does its category compare?
All LGZ devicesLGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Imperial Surgical Ltd. Blanket And Solution Warming Cabinets are designed to store and warm blankets, hospital linens, irrigation fluids and/or injection fluids in accordance with the recommended warming temperatures and storage time guidelines provided by the manufacturers of such products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112702: Imperial Surgical LTD. Blankey and Solution Warning Cabinets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112702
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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