# K080609: SWC/DWC Warming Cabinets

- Pathway: 510(k) (Traditional)
- Applicant: Mac Medical
- Decided: Jun 13, 2008 after 102 days
- Product code: LHC (Warmer, Irrigation Solution)
- Device class: 1
- Regulation: 21 CFR 890.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K993797 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993797: EC-7701 Fluid Warming Cabinet, Enthermics Medical Systems, Inc. (2000) Summary page 4.

## Indications for use
These warming cabinets are designed to store, warm, and maintain the recommended temperature of irrigation solutions prior to use.

Source page: https://510kreport.com/device/K080609
Methodology: https://510kreport.com/methodology