# K102651: Iscreen Vision Screener

- Pathway: 510(k) (Special)
- Applicant: Iscreen Vision, Inc.
- Decided: Jan 12, 2011 after 120 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- 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 K010315 (2001). 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)
- K010315: Iscreen Vision Screener, Iscreen, LLC (2001) Summary page 1.

## Indications for use
The iScreen Vision Screener 3000 is a vision screening tool intended to capture and record red reflex images which contain information on ocular status to aid in eye examination. The iScreen Vision Screener 3000 is intended for use solely for a pediatric population by trained professionals.

Source page: https://510kreport.com/device/K102651
Methodology: https://510kreport.com/methodology