# K260949: Disposable Belts for Polysomnography (CNSAC)

- Pathway: 510(k) (Traditional)
- Applicant: CNSAC Medshop GmbH
- Decided: Sep 24, 2026 after 185 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: 10 generations back to K910772 (1991). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151361: Nox RIP Belts & Cables, Nox Medical Ehf (2015) Summary page 5.

## Indications for use
The CNSAC Disposable Belts for Polysomnography is intended to measure thoracic and/or abdominal respiratory effort during polysomnography (PSG) sleep studies in adult and pediatric patients greater than 2 years of age. The device is used with compatible polysomnography recording systems in clinical sleep laboratories or similar diagnostic environments. The belt is intended for single-patient use and is worn externally around the thorax or abdomen over clothing.

Source page: https://510kreport.com/device/K260949
Methodology: https://510kreport.com/methodology