# K212905: Sotair Device

- Pathway: 510(k) (Traditional)
- Applicant: Safe Bvm Corporation
- Decided: Aug 18, 2022 after 339 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- 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 K894053 (1989). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021328: Smart Bag MO, O-Two Systems International, Inc. (2003) Summary page 4.

## Indications for use
The Sotairm device is intended for use with a manual resuscitator with air-tight connections, in non-breathing patients that require flow controlled ventilation using ambient air or a supplemental oxygen source. The Sotair device is a single use, disposable device added to a manual resuscitator and can be used for in-hospital, emergency, and transport care. The adult Sotair device comprises a flow-limiting valve that limits the inspiratory flow enabling providers to ventilate approximately 55 liters-per-minute (LPM). The flow-limiting valve is intended to minimize gastric inflation during manual ventilation. The Sotair device can be disabled by removing the device, thereby returning the manual resuscitator to its conventional operation. The Sotair device is intended for adult use only.

Source page: https://510kreport.com/device/K212905
Methodology: https://510kreport.com/methodology