# K142076: Claveguard Freedom Surgical Light

- Pathway: 510(k) (Traditional)
- Applicant: Dickson & Dickson Healthcare (Us), Inc.
- Decided: Sep 30, 2014 after 61 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: 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 4.

## Indications for use
The Claveguard Freedom Surgical Light is designed to illuminate the surgical site in Operating theatres

Source page: https://510kreport.com/device/K142076
Methodology: https://510kreport.com/methodology