# K051779: Androflow - Respiratory Rate Monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: Andromed, Inc.
- Decided: Sep 30, 2005 after 91 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
AndrofloTM is intended for use as an adjunct to patient assessment in continuous monitoring of respiratory rate (breathing frequency). Androflo TM is indicated for clinical use in adult patients under the supervision of qualified health care professionals trained in the use of the equipment. AndrofioTM is not intended for home use or for use as an apnea monitor.

Source page: https://510kreport.com/device/K051779
Methodology: https://510kreport.com/methodology