# K970887: Blood Flow Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Paradigm Medical Industries, Inc.
- Decided: Jun 17, 1997 after 98 days
- Product code: HKY (Tonometer, Manual)
- Device class: 2
- Regulation: 21 CFR 886.1930
- 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 K873422 (1987). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K873422: Obf Model 115 Computer Tonometer System, Ocular Blood Flow Laboratories, Inc. (1987) Summary page 1.

## Most influential descendants
- K023245: Blood Flow Analyzer (Bfa), Model 408-100-01 (2002), 0 descendants of its own

## Indications for use
A tonometer and accessories are devices intended to measure intraocular pressure by applying a known force on the globe of the eye to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. We intend the device for use in the diagnosis of glaucoma.

Source page: https://510kreport.com/device/K970887
Methodology: https://510kreport.com/methodology