# K970886: Hanaulux Blue 80 Hospital

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Med GmbH
- Decided: Apr 16, 1997 after 69 days
- Product code: FSS (Light, Surgical, Floor Standing)
- 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. The FDA summary names its predicate without a number.
- (no number) HANAULUX “City” series: named in the summary without a submission number
- (no number) Hanaulux 2000: named in the summary without a submission number
- (no number) Hanaulux® blue 80 Stand: named in the summary without a submission number

## 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.

## Indications for use
Hanaulux blue 80 Hospital is an Examination and Surgical Stand Light.

Source page: https://510kreport.com/device/K970886
Methodology: https://510kreport.com/methodology