# K141638: Propper Insight Binocular Indirect Ophthalmosope

- Pathway: 510(k) (Abbreviated)
- Applicant: Propper Manufacturing Co., Inc.
- Decided: Sep 17, 2014 after 90 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: 3 generations back to K942104 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123316: Heine Omega 500, Heine Optotechnik GmbH & Co. KG (2013) Summary page 5.

## Indications for use
Propper InsightTM Binocular Indirect Ophthalmoscope is an AC-adapter powered or rechargeable battery powered device for medical professionals containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye

Source page: https://510kreport.com/device/K141638
Methodology: https://510kreport.com/methodology