# K864261: Model 3500 Infant Respiration & Heart Rate Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Dyne, Inc.
- Decided: Mar 27, 1987 after 149 days
- Product code: BZQ (Monitor, Breathing Frequency)
- Device class: 2
- Regulation: 21 CFR 868.2375
- 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 has not posted a summary or statement for it, so its predicates are not known.

Source page: https://510kreport.com/device/K864261
Methodology: https://510kreport.com/methodology