# K060822: Vantage Indirect Ophthalmoscope

- Pathway: 510(k) (Special)
- Applicant: Keeler Instruments, Inc.
- Decided: May 23, 2006 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
Longest line of descent: 1 generation back to K942104 (1994). 1 ancestor in all.
3 later devices descend from it; 1 cites 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)
- K942104: Keeler Vantage Indirect Ophthalmoscope, Keeler Instruments, Inc. (1994) Summary page 1.

## 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

## Indications for use
The Keeler Vantage Plus Indirect Ophthalmoscope is intended to be used to examine the Cornea, aqueous, lens, vitreous and retina of the eye.

Source page: https://510kreport.com/device/K060822
Methodology: https://510kreport.com/methodology