# K080857: Chromophare E-Series

- Pathway: 510(k) (Traditional)
- Applicant: Berchtold Holding GmbH
- Decided: Apr 10, 2008 after 14 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K965130 (1997). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965130: Chromophare, Berchtold Holding GmbH (1997) Summary page 1.
- K024132: Chromophare X 65, Berchtold Holding GmbH (2003) Summary page 1.

## Most influential descendants
- K083066: Chromophare E 778 and E 558 (2008), 5 descendants of its own
- K090378: Chromophare E 668 (2009), 2 descendants of its own
- K100388: 21ST Century Centurion Exceled and System Two Led Lighting Systems (2010), 1 descendant of its own
- K142076: Claveguard Freedom Surgical Light (2014), 0 descendants of its own
- K140812: MI-750 Procedural/Minor Surgical Light (2014), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K080857
Methodology: https://510kreport.com/methodology