510(k) · Cleared
ClearedEC-7701 Fluid Warming Cabinet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enthermics Medical Systems, Inc. · LDQ (no longer in FDA’s product-code list)
Cleared on Jan 20, 2000 after a 72-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Jan 20, 2000
- Review
- 72 days
- Product code
- LDQ
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 6 citing it directly.
- This deviceK993797 EC-7701 Fluid Warming CabinetEnthermics Medical Systems, Inc. · 2000
- Descendant · cites it directly · 6 of its ownK092823 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 · cites it directly · 0 of its ownK180842 MAC Medical D-Series Blanket and Solution Warming CabinetsMac Medical, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK153713 Getinge Series Warming CabinetGetinge Sourcing, LLC · 2016
- Descendant · cites it directly · 0 of its ownK132202 DC Series Fluid Warming Cabinet, DC Series Fluid Warming CabinetEnthermics Medical Systems, Inc. · 2013
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K092823Amsco Warming CabinetSTERIS Corporation · 2009 · cites it directly6descendants
- 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 · cites it directly0descendants
- K153713Getinge Series Warming CabinetGetinge Sourcing, LLC · 2016 · 2 generations on0descendants
- K132202DC Series Fluid Warming Cabinet, DC Series Fluid Warming CabinetEnthermics Medical Systems, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993797 | EC-7701 Fluid Warming Cabinet | Enthermics Medical Systems, Inc. | 2000 | — |
| +1 | K092823 | Amsco Warming Cabinet | STERIS Corporation | 2009 | — |
| +1 | 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 | — |
| +2 | K153713 | Getinge Series Warming Cabinet | Getinge Sourcing, LLC | 2016 | — |
| +1 | K132202 | DC Series Fluid Warming Cabinet, DC Series Fluid Warming Cabinet | Enthermics Medical Systems, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 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 LDQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | TempO II™ Warming Cabinet Named without a submission number | |
| * | — | Castle® 5500 Series Warming Cabinets Named without a submission number | |
| * | — | AMSCO Warming Cabinets Named without a submission number |
What descends from it? (10)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092823 | Amsco Warming Cabinet | 2009 | 6 |
| K112702 | Imperial Surgical LTD. Blankey and Solution Warning Cabinets | 2012 | 2 |
| K180842 | MAC Medical D-Series Blanket and Solution Warming Cabinets | 2019 | 0 |
| K132202 | DC Series Fluid Warming Cabinet, DC Series Fluid Warming Cabinet | 2013 | 0 |
| K091336 | Ivnow Modular Fluid Warmer, 120V, Model Ivnow-1, Ivnow-2, Ivnow-3, Ivnow-6, Ivnow… | 2010 | 0 |
| K080609 | SWC/DWC Warming Cabinets | 2008 | 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?
- Of its descendants, K092823 (STERIS Corporation, 2009) has gone furthest, with 6 descendants of its own.
What is it indicated for?
The Enthermics Medical Systems EC-7701 Fluid Warming Cabinet is designed to
safely store and warm irrigation fluids or injection fluids in accordance with the
recommended warming temperatures and storage times stated in the fluid manufacturers’
labeling.
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/K993797 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993797: EC-7701 Fluid Warming Cabinet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993797
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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