# K954169: Hanaulux Blue 30 & 80

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Med GmbH
- Decided: Feb 1, 1996 after 149 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K113679: Lucea Led Surgical Light System (2012), 2 descendants of its own
- K140812: MI-750 Procedural/Minor Surgical Light (2014), 0 descendants of its own
- K130513: Volista 400; Volista 600 (2013), 0 descendants of its own

## Recalls of this device
- Nov 8, 2023 · Class II · Z-0770-2024: A potential for a light system to fall in the operating room.

Source page: https://510kreport.com/device/K954169
Methodology: https://510kreport.com/methodology