# K110486: Accusom

- Pathway: 510(k) (Traditional)
- Applicant: Novasom, Inc.
- Decided: Aug 12, 2011 after 171 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: 4 generations back to K910870 (1991). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000253: Silent Night V, Sleep Solutions, Inc. (2000) Summary page 1.

## Most influential descendants
- K220012: BresoDX1 (2022), 0 descendants of its own

## Indications for use
The ACCUSOM device is indicated for use in the diagnostic evaluation of adults with possible sleep apnea. The ACCUSOM can score obstructive apneas, which includes mixed apneas. The ACCUSOM device is intended for use in the home and clinic setting.

Source page: https://510kreport.com/device/K110486
Methodology: https://510kreport.com/methodology