510(k) · Cleared
ClearedSWC/DWC Warming Cabinets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mac Medical · LHC Warmer, Irrigation Solution
Cleared on Jun 13, 2008 as substantially equivalent to K993797 (Enthermics Medical Systems, Inc., 2000) after a 102-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jun 13, 2008
- Review
- 102 days
- Class
- Class I
- Product code
- LHC
- 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 deviceK080609 SWC/DWC Warming CabinetsMac Medical · 2008
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) | K080609 | SWC/DWC Warming Cabinets | Mac Medical | 2008 | — |
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 LHC? 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? (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 4…ing Cabinets Classification Name: Warmer, irrigation-solution <Qbinet Product Code BHE L:DQ Common/Usual Name: Imrigation-Wasmer . Equivalent legally marketed devices: K993797, Enthermics Medical Systems Fluid Warming Cabinet . Indications for Use (intended use) These warming cabinets are desngned to st… | 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 LHC devicesLHC Warmer, Irrigation Solution: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LHC
2in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · LHC
Too few LHC 510(k)s in any year since 2007 to give a median.
Recalls per year · LHC
8in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LHC
6in 2025
MAUDE reports naming product code LHC, 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 | 0 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 1 | — | 8 | 13 |
| 2016 | 2 | — | 0 | 69 |
| 2017 | 0 | — | 0 | 33 |
| 2018 | 0 | — | 0 | 30 |
| 2019 | 0 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
These warming cabinets are designed to store, warm, and maintain the recommended temperature of irrigation solutions prior to use.
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/K080609 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080609: SWC/DWC Warming Cabinets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080609
Report an extraction error
Are you the manufacturer?
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