# K090378: Chromophare E 668

- Pathway: 510(k) (Traditional)
- Applicant: Berchtold GmbH & Co. KG
- Decided: Feb 23, 2009 after 6 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: 4 generations back to K965130 (1997). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083066: Chromophare E 778 and E 558, Berchtold Holding GmbH (2008) Summary page 1.

## Most influential descendants
- K142076: Claveguard Freedom Surgical Light (2014), 0 descendants of its own
- K120392: Chromophare F 628 and F 528 (2012), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K090378
Methodology: https://510kreport.com/methodology