# K180001: Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant

- Pathway: 510(k) (Abbreviated)
- Applicant: Embla Systems
- Decided: Sep 27, 2019 after 633 days
- Product code: MNR (Ventilatory Effort Recorder)
- 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: 2 generations back to K903300 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913749: Edentrace Airflow 3171/Sleep Lab Airflow 3170, Edentec Corp. (1992) Summary page 4.
- K042253: Sleepsense Sleep Sensors, S.L.P., Ltd. (2004) Summary page 4.

## Indications for use
The Embla BreathSensor provides a qualitative air flow signal by oral and/or nasal temperature sensitive resistive components for recording onto a recording system in support of airflow analysis and sleep studies. The Embla BreathSensor does not provide any diagnostic conclusion about the patient’s condition to the user. The Embla BreathSensor user is a qualified medical practitioner in a hospital environment only who will exercise their professional judgment in using this information.

Source page: https://510kreport.com/device/K180001
Methodology: https://510kreport.com/methodology