510(k) · Cleared
ClearedDC Series Fluid Warming Cabinet, DC Series Fluid Warming Cabinet
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 Dec 6, 2013 as substantially equivalent to K993797 (Enthermics Medical Systems, Inc., 2000) after a 143-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Dec 6, 2013
- Review
- 143 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993797 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK993797 EC-7701 Fluid Warming CabinetEnthermics Medical Systems, Inc. · 2000
- This deviceK132202 DC Series Fluid Warming Cabinet, DC Series Fluid Warming CabinetEnthermics Medical Systems, Inc. · 2013
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) | K132202 | DC Series Fluid Warming Cabinet, DC Series Fluid Warming Cabinet | Enthermics Medical Systems, Inc. | 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 |
|---|---|---|---|
| * | K993797 | EC-7701 Fluid Warming CabinetSummary page 1…Unclassified Product Code: LGZ, Warmer, Thermal, Infusion Fluid C. Predicate Device Enthermics Medical Systems, EC-7701 Fluid Warming Cabinet (K993797) D. Device Description The DC Series Fluid Warming Cabinets are single cavity warming cabinets intended to heat either… | 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?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K993797.
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 Enthermics Medical Systems DC Series Fluid Warming Cabinets are designed to store and warm irrigation fluids and injection fluids in accordance with the recommended warming temperatures and storage times stated in the fluid manufacturers' labeling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132202 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132202: DC Series Fluid Warming Cabinet, DC Series Fluid 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/K132202
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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