# K032430: Acueity Medical Light Source

- Pathway: 510(k) (Traditional)
- Applicant: Acueity, Inc.
- Decided: Sep 5, 2003 after 30 days
- Product code: FCW (Light Source, Fiberoptic, Routine)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951647 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951647: Welch Allyn HI - Lux Illuminator, Welch Allyn, Inc. (1995) Summary page 2.

## Indications for use
The Acueity Medical Light Source is indicated for use in illuminating the operative site and providing video images that can be displayed on a monitor. The device is designed for attachment to endoscopes and laparoscopes that are used in medical procedures.

Source page: https://510kreport.com/device/K032430
Methodology: https://510kreport.com/methodology