# K942712: Neitz Halogen Binocular Indirect Ophthalmoscope IO-a

- Pathway: 510(k) (Traditional)
- Applicant: Neitz Instruments Company, Ltd.
- Decided: Aug 5, 1994 after 57 days
- Product code: HLI (Ophthalmoscope, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K123316: Heine Omega 500 (2013), 2 descendants of its own
- K142837: Heine Sigma 250 & Heine Sigma 250 M2 (2015), 0 descendants of its own
- K141638: Propper Insight Binocular Indirect Ophthalmosope (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K942712
Methodology: https://510kreport.com/methodology