# K943678: Electronic Flow Meter

- Pathway: 510(k) (Traditional)
- Applicant: Vitalograph, Inc.
- Decided: Dec 14, 1995 after 506 days
- Product code: BZH (Meter, Peak Flow, Spirometry)
- Device class: 2
- Regulation: 21 CFR 868.1860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 1 cites it directly.
0 of 22 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
- K982995: Accutrax, Model EPF840 (1998), 20 descendants of its own
- K031024: Microlife Electronic Peak Flow Monitor, Model PF-100 (2003), 10 descendants of its own
- K040723: Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and PF-100-1 (with Software) (2004), 9 descendants of its own
- K022276: Kokomate (2002), 8 descendants of its own
- K051572: Koko Legend (2005), 7 descendants of its own

Source page: https://510kreport.com/device/K943678
Methodology: https://510kreport.com/methodology