# K220012: BresoDX1

- Pathway: 510(k) (Traditional)
- Applicant: Bresotec, Inc.
- Decided: Dec 21, 2022 after 351 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: 5 generations back to K910870 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110486: Accusom, Novasom, Inc. (2011) Summary page 4.

## Indications for use
BresoDX1 is indicated for use as an aid in the diagnosis of moderate to severe sleep apnea in adult patients. BresoDX1 records a patient’s physiological signals during sleep and scores apneas and hypopneas. BresoDX1 is intended to be used in the home and clinic settings.

Source page: https://510kreport.com/device/K220012
Methodology: https://510kreport.com/methodology