510(k) · Cleared
ClearedChromophare X 65
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Berchtold Holding GmbH · FSY Light, Surgical, Ceiling Mounted
Cleared on Mar 21, 2003 as substantially equivalent to K965130 (Berchtold Holding GmbH, 1997) after a 95-day review. Its family tree reaches back 1 generation to 1997. 23 later devices descend from it.
- Decided
- Mar 21, 2003
- Review
- 95 days
- Class
- Class II
- Product code
- FSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K965130 (1997). 23 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK965130 ChromophareBerchtold Holding GmbH · 1997
- This deviceK024132 Chromophare X 65Berchtold Holding GmbH · 2003
- Descendant · cites it directly · 16 of its ownK061317 ILEDTrumpf Kreuzer Medizin Systeme GmbH + Co.Kg · 2006 · Recalled
- Descendant · 2 generations on · 10 of its ownK072072 Harmony Led-1 Surgical Lighting SystemSTERIS Corporation · 2007 · Recalled
- Descendant · cites it directly · 6 of its ownK080857 Chromophare E-SeriesBerchtold Holding GmbH · 2008
- Descendant · 2 generations on · 5 of its ownK083066 Chromophare E 778 and E 558Berchtold Holding GmbH · 2008
- Descendant · 3 generations on · 4 of its ownK093009 Mach Led SCDr. Mach GmbH & Co. KG · 2010
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K061317ILEDTrumpf Kreuzer Medizin Systeme GmbH + Co.Kg · 2006 · cites it directly16descendants
- K072072Harmony Led-1 Surgical Lighting SystemSTERIS Corporation · 2007 · 2 generations on10descendants
- K080857Chromophare E-SeriesBerchtold Holding GmbH · 2008 · cites it directly6descendants
- K083066Chromophare E 778 and E 558Berchtold Holding GmbH · 2008 · 2 generations on5descendants
- K093009Mach Led SCDr. Mach GmbH & Co. KG · 2010 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K965130 | Chromophare | Berchtold Holding GmbH | 1997 | — |
| 0 (this device) | K024132 | Chromophare X 65 | Berchtold Holding GmbH | 2003 | — |
| +1 | K061317 | ILED | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2006 | 7 |
| +2 | K072072 | Harmony Led-1 Surgical Lighting System | STERIS Corporation | 2007 | 1 |
| +1 | K080857 | Chromophare E-Series | Berchtold Holding GmbH | 2008 | — |
| +2 | K083066 | Chromophare E 778 and E 558 | Berchtold Holding GmbH | 2008 | — |
| +3 | K093009 | Mach Led SC | Dr. Mach GmbH & Co. KG | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 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 FSY? 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 |
|---|---|---|---|
| * | K965130 | ChromophareSummary page 1…e BERCHTOLD CHROMOPHARE@X65 is substantially equivalent to the surgical light BERCHTOLD CHROMOPHARE@D650 (K965130). Any difference that exists between the CHROMOPHARE@ D650 and the X 65 has no… | 1997 |
What descends from it? (23)
See all 233 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All FSY devicesFSY Light, Surgical, Ceiling Mounted: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FSY
7in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · FSY
59in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FSY
11in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FSY
286in 2025
MAUDE reports naming product code FSY, 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 | 3 | 29 | 0 | 70 |
| 2008 | 2 | — | 0 | 53 |
| 2009 | 2 | — | 4 | 40 |
| 2010 | 5 | 130 | 3 | 72 |
| 2011 | 0 | — | 4 | 70 |
| 2012 | 2 | — | 4 | 171 |
| 2013 | 3 | 118 | 1 | 137 |
| 2014 | 7 | 59 | 0 | 139 |
| 2015 | 0 | — | 228 | 175 |
| 2016 | 0 | — | 0 | 182 |
| 2017 | 0 | — | 0 | 162 |
| 2018 | 0 | — | 2 | 316 |
| 2019 | 0 | — | 4 | 444 |
| 2020 | 0 | — | 0 | 439 |
| 2021 | 0 | — | 0 | 380 |
| 2022 | 0 | — | 0 | 430 |
| 2023 | 0 | — | 11 | 663 |
| 2024 | 0 | — | 0 | 541 |
| 2025 | 0 | — | 0 | 286 |
| 2026 | 0 | — | 4 | — |
What is it indicated for?
The surgical light BERCHTOLD CHROMOPHARE'* X65 is intended to illuminate tocaily the operating site on the patient's body with a high intensity, shadow free, "cold" light.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024132: Chromophare X 65.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024132
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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