# K023245: Blood Flow Analyzer (Bfa), Model 408-100-01

- Pathway: 510(k) (Traditional)
- Applicant: Paradigm Medical Industries, Inc.
- Decided: Oct 21, 2002 after 21 days
- Product code: NJJ (Tonometer, Analyzer, Ocular Blood Flow)
- 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: 2 generations back to K873422 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970887: Blood Flow Analyzer, Paradigm Medical Industries, Inc. (1997) Summary page 1.

## Indications for use
Tonometry for Measuring and Recording Intraocular Pressures and Intraocular Pressure Pulse Amplitudes Pulsatile Ocular Blood Flow Pulsatile Ocular Blood Volume Pulsatility Equivalence Index (PEQ)

Source page: https://510kreport.com/device/K023245
Methodology: https://510kreport.com/methodology