# K851742: Medical Examination Lights

- Pathway: 510(k) (Traditional)
- Applicant: Burton Medical Products Corp.
- Decided: May 13, 1985 after 14 days
- Product code: KZF (Device, Medical Examination, Ac Powered)
- Device class: 1
- Regulation: 21 CFR 880.6320
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Feb 19, 2004 · Not classified · Z-0589-04: Pivot joint on these ceiling mount lights may fail and lights may fall onto patients.

Source page: https://510kreport.com/device/K851742
Methodology: https://510kreport.com/methodology
