# K932451: Hanaulux 2005 Surgical Light

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Instruments GmbH
- Decided: Nov 12, 1993 after 176 days
- Product code: FTD (Lamp, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Nov 8, 2023 · Class II · Z-0768-2024: A potential for a light system to fall in the operating room.

Source page: https://510kreport.com/device/K932451
Methodology: https://510kreport.com/methodology