# K964338: RI-Tiniscope-Slit/RI-Tiniscope Spot/RI-Vision-Slit/RI-Vision-Spot

- Pathway: 510(k) (Traditional)
- Applicant: Rudolf Riester GmbH & Co. KG
- Decided: Jan 9, 1997 after 70 days
- Product code: HKM (Retinoscope, Battery-Powered)
- Device class: 1
- Regulation: 21 CFR 886.1780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Source page: https://510kreport.com/device/K964338
Methodology: https://510kreport.com/methodology