510(k) · Cleared
ClearedChromophare E 668
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 23, 2009 as substantially equivalent to K083066 (Berchtold Holding GmbH, 2008) after a 6-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.
- Decided
- Feb 23, 2009
- Review
- 6 days
- Class
- Class II
- Product code
- FSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K965130 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK965130 ChromophareBerchtold Holding GmbH · 1997
- 3 generations backK024132 Chromophare X 65Berchtold Holding GmbH · 2003
- 2 generations backK080857 Chromophare E-SeriesBerchtold Holding GmbH · 2008
- 1 generation backK083066 Chromophare E 778 and E 558Berchtold Holding GmbH · 2008
- This deviceK090378 Chromophare E 668Berchtold GmbH & Co. KG · 2009
- Descendant · cites it directly · 0 of its ownK142076 Claveguard Freedom Surgical LightDickson & Dickson Healthcare (Us), Inc. · 2014
- Descendant · cites it directly · 0 of its ownK120392 Chromophare F 628 and F 528Berchtold GmbH & Co. KG · 2012 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K965130 | Chromophare | Berchtold Holding GmbH | 1997 | — |
| −3 | K024132 | Chromophare X 65 | Berchtold Holding GmbH | 2003 | — |
| −2 | K080857 | Chromophare E-Series | Berchtold Holding GmbH | 2008 | — |
| −1 | K083066 | Chromophare E 778 and E 558 | Berchtold Holding GmbH | 2008 | — |
| 0 (this device) | K090378 | Chromophare E 668 | Berchtold GmbH & Co. KG | 2009 | — |
| +1 | K142076 | Claveguard Freedom Surgical Light | Dickson & Dickson Healthcare (Us), Inc. | 2014 | — |
| +1 | K120392 | Chromophare F 628 and F 528 | Berchtold GmbH & Co. KG | 2012 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 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 |
|---|---|---|---|
| * | K083066 | Chromophare E 778 and E 558Summary page 1…CHROMOPHAREO E 668 Com~mon Name: Surgical lamp Classification Name: Light, Surgical, Ceiling mounted Predicate Device: BERCHTOLD CHROMOPHAREO E 558 (K083066) Device Description: The new BERCHTOLD CHROMOPHAREO E.668 surgical light is suitable for all types of… | 2008 |
What descends from it? (2)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K142076 (Dickson & Dickson Healthcare (Us), Inc., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K083066.
How does its category compare?
All FSY devicesFSY Light, Surgical, Ceiling Mounted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 light BERCHTOLD CHROMOPHARE® E 668 is 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/K090378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090378: Chromophare E 668.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090378
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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