# K983449: Gereonics  Ultra-Piezo Respiratory Effort Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Gereonics, Inc.
- Decided: Feb 8, 1999 after 131 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
Longest line of descent: 1 generation back to K923402 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923402: Crystal Trace Piezo Respiratory Effort Sensor, Pro-Tech, Inc. (1992) Summary page 2.

## Indications for use
The Gereonics Ultra-Piezo Respiratory Effort Sensor is intended for use in sleep disorders studies to measure respiratory effort for monitoring or recording on a physiological recording system. The Ultra-Piezo Respiratory Effort Sensor is NOT intended for use as an Apnea Alarm.

Source page: https://510kreport.com/device/K983449
Methodology: https://510kreport.com/methodology