510(k) · Cleared
Recalled · Class II · 2026Chromophare F 628 and F 528
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Berchtold GmbH & Co. KG · FSY Light, Surgical, Ceiling Mounted
Cleared on Feb 16, 2012 as substantially equivalent to K090378 (Berchtold GmbH & Co. KG, 2009) after an 8-day review. Its family tree reaches back 5 generations to 1997. It has been recalled 2 times.
- Decided
- Feb 16, 2012
- Review
- 8 days
- Class
- Class II
- Product code
- FSY
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K965130 (1997). No later device cites it as a predicate yet.
- Root · 5 generations backK965130 ChromophareBerchtold Holding GmbH · 1997
- 4 generations backK024132 Chromophare X 65Berchtold Holding GmbH · 2003
- 3 generations backK080857 Chromophare E-SeriesBerchtold Holding GmbH · 2008
- 2 generations backK083066 Chromophare E 778 and E 558Berchtold Holding GmbH · 2008
- 1 generation backK090378 Chromophare E 668Berchtold GmbH & Co. KG · 2009
- This deviceK120392 Chromophare F 628 and F 528Berchtold GmbH & Co. KG · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K965130 | Chromophare | Berchtold Holding GmbH | 1997 | — |
| −4 | K024132 | Chromophare X 65 | Berchtold Holding GmbH | 2003 | — |
| −3 | K080857 | Chromophare E-Series | Berchtold Holding GmbH | 2008 | — |
| −2 | K083066 | Chromophare E 778 and E 558 | Berchtold Holding GmbH | 2008 | — |
| −1 | K090378 | Chromophare E 668 | Berchtold GmbH & Co. KG | 2009 | — |
| 0 (this device) | K120392 | Chromophare F 628 and F 528 | Berchtold GmbH & Co. KG | 2012 | — |
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 |
|---|---|---|---|
| * | K090378 | Chromophare E 668Summary page 1…HROMOPHARE® F 528 Common Name: Surgical lamp Classification Name: Light, Surgical, Ceiling mounted Predicate Device: BERCHTOLD CHROMOPHARE® E 668 (K090378) Device Description: The new BERCHTOLD CHROMOPHARE® F 628 and F 528 surgical lights are suitable for… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 23, 2026 | Class II | Z-1688-2026 | Unknown/Undetermined by firm | Surgical light assembly may not adequate support the weight of the ceiling cover. |
| Feb 8, 2024 | Class II | Z-1506-2024 | Employee error | Due to insufficient mounting force the stability of surgical light system cannot be guaranteed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K090378.
How does its category compare?
All FSY devicesFSY Light, Surgical, Ceiling Mounted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 lights BERCHTOLD CHROMOPHARE F 628 and F 528 are intended to illuminate locally 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/K120392 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120392: Chromophare F 628 and F 528.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120392
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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