# K895715: Hanaulux (R) 2000

- Pathway: 510(k) (Traditional)
- Applicant: W.C. Heraeus GmbH
- Decided: Oct 13, 1989 after 18 days
- Product code: FTD (Lamp, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: 4 (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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Oct 7, 2009 · Not classified · Z-0184-2010: Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front j
- Oct 7, 2009 · Not classified · Z-0185-2010: Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front j
- Oct 7, 2009 · Not classified · Z-0182-2010: Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front j
- Oct 7, 2009 · Not classified · Z-0183-2010: Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front j

Source page: https://510kreport.com/device/K895715
Methodology: https://510kreport.com/methodology