# K120392: Chromophare F 628 and F 528

- Pathway: 510(k) (Traditional)
- Applicant: Berchtold GmbH & Co. KG
- Decided: Feb 16, 2012 after 8 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K965130 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090378: Chromophare E 668, Berchtold GmbH & Co. KG (2009) Summary page 1.

## Recalls of this device
- Feb 23, 2026 · Class II · Z-1688-2026: Surgical light assembly may not adequate support the weight of the ceiling cover.
- Feb 8, 2024 · Class II · Z-1506-2024: Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.

## Indications for use
The surgical lights BERCHTOLD CHROMOPHARE F 628 and F 528 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/K120392
Methodology: https://510kreport.com/methodology