510(k) · Cleared
ClearedChromophare E 778 and E 558
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 30, 2008 as substantially equivalent to K080857 (Berchtold Holding GmbH, 2008) after a 15-day review. Its family tree reaches back 3 generations to 1997. 5 later devices descend from it.
- Decided
- Oct 30, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- FSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K965130 (1997). 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK965130 ChromophareBerchtold Holding GmbH · 1997
- 2 generations backK024132 Chromophare X 65Berchtold Holding GmbH · 2003
- 1 generation backK080857 Chromophare E-SeriesBerchtold Holding GmbH · 2008
- This deviceK083066 Chromophare E 778 and E 558Berchtold Holding GmbH · 2008
- Descendant · cites it directly · 2 of its ownK090378 Chromophare E 668Berchtold GmbH & Co. KG · 2009
- Descendant · cites it directly · 1 of its ownK100388 21ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK142076 Claveguard Freedom Surgical LightDickson & Dickson Healthcare (Us), Inc. · 2014
- Descendant · cites it directly · 0 of its ownK140812 MI-750 Procedural/Minor Surgical LightMedical Illumination International, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK120392 Chromophare F 628 and F 528Berchtold GmbH & Co. KG · 2012 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K090378Chromophare E 668Berchtold GmbH & Co. KG · 2009 · cites it directly2descendants
- K10038821ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc. · 2010 · cites it directly1descendant
- K142076Claveguard Freedom Surgical LightDickson & Dickson Healthcare (Us), Inc. · 2014 · 2 generations on0descendants
- K140812MI-750 Procedural/Minor Surgical LightMedical Illumination International, Inc. · 2014 · cites it directly0descendants
- K120392Chromophare F 628 and F 528Berchtold GmbH & Co. KG · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K965130 | Chromophare | Berchtold Holding GmbH | 1997 | — |
| −2 | K024132 | Chromophare X 65 | Berchtold Holding GmbH | 2003 | — |
| −1 | K080857 | Chromophare E-Series | Berchtold Holding GmbH | 2008 | — |
| 0 (this device) | K083066 | Chromophare E 778 and E 558 | Berchtold Holding GmbH | 2008 | — |
| +1 | K090378 | Chromophare E 668 | Berchtold GmbH & Co. KG | 2009 | — |
| +1 | K100388 | 21ST Century Centurion Exceled and System Two Led Lighting Systems | Medical Illumination International, Inc. | 2010 | — |
| +2 | K142076 | Claveguard Freedom Surgical Light | Dickson & Dickson Healthcare (Us), Inc. | 2014 | — |
| +1 | K140812 | MI-750 Procedural/Minor Surgical Light | Medical Illumination International, Inc. | 2014 | — |
| +2 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 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 |
|---|---|---|---|
| * | K080857 | Chromophare E-SeriesSummary page 1…CHROMOPHAREO E 558 Common Name: Surgical lamp Classification Name: Light, Surgical, Ceiling mounted Predicate Device: BERCHTOLD CHROMOPHAREO E 655 (K080857) Device Description: The new BERCHTOLD CHROMOPHAREO E 778 and E 558 surgical lights are suitable for… | 2008 |
What descends from it? (5)
3 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 11 years and passes through 1 company; a new generation was cleared every 5.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K090378 (Berchtold GmbH & Co. KG, 2009) has gone furthest, with 2 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. 2008, 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® E 778 and E 558 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/K083066 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083066: Chromophare E 778 and E 558.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083066
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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