510(k) · Cleared
Recalled · 2009Chromophare
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 Oct 9, 1992 after a 119-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it. It has been recalled once.
- Decided
- Oct 9, 1992
- Review
- 119 days
- Class
- Class II
- Product code
- FSY
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK922836 ChromophareBerchtold Holding GmbH · 1992
- Descendant · cites it directly · 3 of its ownK031068 Stryker Visum Surgical Lighting SystemStryker Endoscopy · 2003 · Recalled
- Descendant · cites it directly · 2 of its ownK982063 Alm Prismalix (PRX) Surgical LightAlm Surgical Equipment, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 1 of its ownK060802 Visum Led Surgical Lighting SystemStryker Communications Corp. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK132551 ZF 720Umbel Corporation · 2014
- Descendant · 3 generations on · 0 of its ownK132747 Visum Blade Led Surgical Lighting SystemStryker Communications · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K031068Stryker Visum Surgical Lighting SystemStryker Endoscopy · 2003 · cites it directly3descendants
- K982063Alm Prismalix (PRX) Surgical LightAlm Surgical Equipment, Inc. · 1998 · cites it directly2descendants
- K060802Visum Led Surgical Lighting SystemStryker Communications Corp. · 2006 · 2 generations on1descendant
- K132551ZF 720Umbel Corporation · 2014 · 2 generations on0descendants
- K132747Visum Blade Led Surgical Lighting SystemStryker Communications · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922836 | Chromophare | Berchtold Holding GmbH | 1992 | — |
| +1 | K031068 | Stryker Visum Surgical Lighting System | Stryker Endoscopy | 2003 | 8 |
| +1 | K982063 | Alm Prismalix (PRX) Surgical Light | Alm Surgical Equipment, Inc. | 1998 | 1 |
| +2 | K060802 | Visum Led Surgical Lighting System | Stryker Communications Corp. | 2006 | 4 |
| +2 | K132551 | ZF 720 | Umbel Corporation | 2014 | — |
| +3 | K132747 | Visum Blade Led Surgical Lighting System | Stryker Communications | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 16, 2009 | Not classified | Z-0591-2011 | Other | A mechanical failure of a welded joint within the spring Arm may result in the rapid drop of a monitor to the mechanical stop. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031068 (Stryker Endoscopy, 2003) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K922836 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922836: Chromophare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922836
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026