510(k) · Cleared
ClearedC Change Solution Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C Change Surgical, LLC · LHC Warmer, Irrigation Solution
Cleared on Aug 15, 2005 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) after a 41-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Aug 15, 2005
- Review
- 41 days
- Class
- Class I
- Product code
- LHC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to P960025 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backP960025 Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle…Depuy Spine, Inc. · 1999
- This deviceK051819 C Change Solution WarmerC Change Surgical, LLC · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws | Depuy Spine, Inc. | 1999 | — |
| 0 (this device) | K051819 | C Change Solution Warmer | C Change Surgical, LLC | 2005 | — |
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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K100042 | FDA’s K100042 is Difusion Technologies Xiphos Interbody Fusion System 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…age 5 === IDENTIFICATION OF PREDICATE DEVICE(S) Predicate devices include various cleared interbody fusion systems: Primary - DiFusion: Xiphos Interbody Fusion System (K100042) Secondary Additional Predicate - DePuy Acromed: Lumbar I/F Cage (P960025) Reference Devices - Eminent Spine: Eminent Spine In… | 2010 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 5…various cleared interbody fusion systems: Primary - DiFusion: Xiphos Interbody Fusion System (K100042) Secondary Additional Predicate - DePuy Acromed: Lumbar I/F Cage (P960025) Reference Devices - Eminent Spine: Eminent Spine Interbody Fusion System (K090064) - Medtronic: InterFix System (P970015) -… | 1999 |
| † | K090064 | Eminent Spine Interbody Fusion System | 2009 |
| † | P970015 | Inter Fix Threaded Fusion Device | 1999 |
| † | K082310 | Hollywood, Pacifica, Redondo, Ventura | 2008 |
| † | K130573 | Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif | 2013 |
| † | K092193 | Spinal Usa Interbody Cages | 2009 |
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.
- 98 other devices also cite its predicate P960025.
How does its category compare?
All LHC devicesLHC Warmer, Irrigation Solution: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The C Change Solution Warmer is designed to warm and maintain the temperature of
surgical solutions prior to their 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/K051819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051819: C Change Solution Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051819
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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