510(k) · Cleared
ClearedChromophare E-Series
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 Apr 10, 2008 as substantially equivalent to K965130 (Berchtold Holding GmbH, 1997) and 1 other predicate after a 14-day review. Its family tree reaches back 2 generations to 1997. 6 later devices descend from it.
- Decided
- Apr 10, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- FSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K965130 (1997). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK965130 ChromophareBerchtold Holding GmbH · 1997
- 1 generation backK024132 Chromophare X 65Berchtold Holding GmbH · 2003
- This deviceK080857 Chromophare E-SeriesBerchtold Holding GmbH · 2008
- Descendant · cites it directly · 5 of its ownK083066 Chromophare E 778 and E 558Berchtold Holding GmbH · 2008
- Descendant · 2 generations on · 2 of its ownK090378 Chromophare E 668Berchtold GmbH & Co. KG · 2009
- Descendant · 2 generations on · 1 of its ownK100388 21ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK142076 Claveguard Freedom Surgical LightDickson & Dickson Healthcare (Us), Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK140812 MI-750 Procedural/Minor Surgical LightMedical Illumination International, Inc. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K083066Chromophare E 778 and E 558Berchtold Holding GmbH · 2008 · cites it directly5descendants
- K090378Chromophare E 668Berchtold GmbH & Co. KG · 2009 · 2 generations on2descendants
- K10038821ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc. · 2010 · 2 generations on1descendant
- K142076Claveguard Freedom Surgical LightDickson & Dickson Healthcare (Us), Inc. · 2014 · 3 generations on0descendants
- K140812MI-750 Procedural/Minor Surgical LightMedical Illumination International, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K965130 | Chromophare | Berchtold Holding GmbH | 1997 | — |
| −1 | K024132 | Chromophare X 65 | Berchtold Holding GmbH | 2003 | — |
| 0 (this device) | K080857 | Chromophare E-Series | Berchtold Holding GmbH | 2008 | — |
| +1 | K083066 | Chromophare E 778 and E 558 | Berchtold Holding GmbH | 2008 | — |
| +2 | K090378 | Chromophare E 668 | Berchtold GmbH & Co. KG | 2009 | — |
| +2 | K100388 | 21ST Century Centurion Exceled and System Two Led Lighting Systems | Medical Illumination International, Inc. | 2010 | — |
| +3 | K142076 | Claveguard Freedom Surgical Light | Dickson & Dickson Healthcare (Us), Inc. | 2014 | — |
| +2 | K140812 | MI-750 Procedural/Minor Surgical Light | Medical Illumination International, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K965130 | ChromophareSummary page 1…CHROMOPHARE® E 520 Common Name: Surgical lamp Classification Name: Light, Surgical, Ceiling mounted Predicate Device: BERCHTOLD CHROMOPHARE® D650 (K965130) BERCHTOLD CHROMOPHARE® X65 (K024132) Device Description: The new BERCHTOLD CHROMOPHARE® E805, E800, E6… | 1997 |
| * | K024132 | Chromophare X 65Summary page 1…Classification Name: Light, Surgical, Ceiling mounted Predicate Device: BERCHTOLD CHROMOPHARE® D650 (K965130) BERCHTOLD CHROMOPHARE® X65 (K024132) Device Description: The new BERCHTOLD CHROMOPHARE® E805, E800, E655, E650, E550, and E520 (collectivel… | 2003 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083066 | Chromophare E 778 and E 558 | 2008 | 5 |
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 5.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K083066 (Berchtold Holding GmbH, 2008) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K965130.
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 805, E 800, E 655, E 650, E 550 and E 520 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/K080857 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080857: Chromophare E-Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080857
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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