# K950461: Welch Allyn Ophthalmoscope

- Pathway: 510(k) (Traditional)
- Applicant: Welch Allyn, Inc.
- Decided: Apr 4, 1995 after 60 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K102412: Vista Digital Opthalmoscope (2011), 2 descendants of its own
- K121405: Panoptic (2012), 1 descendant of its own
- K223381: iExaminer System with Panoptic Plus (2023), 0 descendants of its own
- K131939: Amico DH-W35 Ophthalmoscope Series (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K950461
Methodology: https://510kreport.com/methodology