# K922112: Easyflow

- Pathway: 510(k) (Traditional)
- Applicant: Epm Information Systems, Inc.
- Decided: Dec 7, 1992 after 216 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K042253: Sleepsense Sleep Sensors (2004), 4 descendants of its own
- K173793: XactTrace Single Use Respiratory Effort Belt System (2019), 1 descendant of its own
- K242424: Bluebird Single-Use Respiratory Effort Belt (2024), 0 descendants of its own
- K201495: Maxxi Flow Sensor (2020), 0 descendants of its own
- K180001: Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K922112
Methodology: https://510kreport.com/methodology