# K131939: Amico DH-W35 Ophthalmoscope Series

- Pathway: 510(k) (Traditional)
- Applicant: Amico Diagnostic Incorporated
- Decided: Mar 26, 2014 after 272 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
Longest line of descent: 1 generation back to K950461 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950461: Welch Allyn Ophthalmoscope, Welch Allyn, Inc. (1995) Summary page 1.

## Indications for use
An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.

Source page: https://510kreport.com/device/K131939
Methodology: https://510kreport.com/methodology