# K051819: C Change Solution Warmer

- Pathway: 510(k) (Traditional)
- Applicant: C Change Surgical, LLC
- Decided: Aug 15, 2005 after 41 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 P960025 (1999). 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)
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 5.

## Cited in the summary but kept off the family tree
- K100042: Difusion Technologies Xiphos Interbody Fusion System, Difusion Technologies (2010). Our OCR of the scanned summary read K100042, which FDA decided on Oct 1, 2010, after this device was decided (Aug 15, 2005), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 5.

## Indications for use
The C Change Solution Warmer is designed to warm and maintain the temperature of surgical solutions prior to their use.

Source page: https://510kreport.com/device/K051819
Methodology: https://510kreport.com/methodology