# K943955: Retina Flowmeter

- Pathway: 510(k) (Traditional)
- Applicant: Heidelberg Engineering
- Decided: Nov 14, 1994 after 91 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices 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.

## Most influential descendants
- K992606: Canon Laser Blood Flowmeter (CLBF) Model 100 (2000), 4 descendants of its own
- K062416: Retinal Functional Imager (Rfi) (2006), 3 descendants of its own
- K080180: Modification to Retinal Function Imager (Rfi) (2008), 1 descendant of its own
- K193319: XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System (2020), 0 descendants of its own
- K153239: LSFG-Navi (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K943955
Methodology: https://510kreport.com/methodology