# K003376: Welch Allyn 11800 Opthalmoscope

- Pathway: 510(k) (Abbreviated)
- Applicant: Welch Allyn, Inc.
- Decided: Jan 25, 2001 after 87 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.
23 later devices descend from it; 3 cite it directly.
0 of 24 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
- K092056: Optomed Smartscope, Model M3-1 EY1 (2009), 22 descendants of its own
- K110986: Optomed Smartscope M5 EY3 and M5 ES1 (2011), 20 descendants of its own
- K132186: Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope ES2 (2013), 9 descendants of its own
- K120982: Digital Eye-Fundus Camera (2012), 6 descendants of its own
- K180378: Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module (2018), 4 descendants of its own

Source page: https://510kreport.com/device/K003376
Methodology: https://510kreport.com/methodology