510(k) · Cleared
ClearedChromophare
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 Jul 14, 1997 after a 203-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 27 later devices descend from it.
- Decided
- Jul 14, 1997
- Review
- 203 days
- Class
- Class II
- Product code
- FSY
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 4 citing it directly.
- This deviceK965130 ChromophareBerchtold Holding GmbH · 1997
- Descendant · cites it directly · 23 of its ownK024132 Chromophare X 65Berchtold Holding GmbH · 2003
- Descendant · 2 generations on · 16 of its ownK061317 ILEDTrumpf Kreuzer Medizin Systeme GmbH + Co.Kg · 2006 · Recalled
- Descendant · 3 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
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K024132Chromophare X 65Berchtold Holding GmbH · 2003 · cites it directly23descendants
- K061317ILEDTrumpf Kreuzer Medizin Systeme GmbH + Co.Kg · 2006 · 2 generations on16descendants
- K072072Harmony Led-1 Surgical Lighting SystemSTERIS Corporation · 2007 · 3 generations on10descendants
- K080857Chromophare E-SeriesBerchtold Holding GmbH · 2008 · cites it directly6descendants
- K083066Chromophare E 778 and E 558Berchtold Holding GmbH · 2008 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K965130 | Chromophare | Berchtold Holding GmbH | 1997 | — |
| +1 | K024132 | Chromophare X 65 | Berchtold Holding GmbH | 2003 | — |
| +2 | K061317 | ILED | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2006 | 7 |
| +3 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
| 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (27)
See all 274 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?
- Of its descendants, K024132 (Berchtold Holding GmbH, 2003) has gone furthest, with 23 descendants of its own.
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, CHROMOPHARE® D-650. is intended to illuminate locally the operating site on the patient's body with a high light intensity. “cold” light.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K965130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K965130: Chromophare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965130
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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