# K021328: Smart Bag MO

- Pathway: 510(k) (Traditional)
- Applicant: O-Two Systems International, Inc.
- Decided: Jun 26, 2003 after 426 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: 3 generations back to K894053 (1989). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973419: DMR Plus Disposable Manual Resuscitator, Nellcor Puritan Bennett, Inc. (1998) Summary page 1.

## Most influential descendants
- K212905: Sotair Device (2022), 0 descendants of its own

## Indications for use
The SMART BAG@MD is intended for manual ventilation of patients using ambient air or supplemental oxygen supplied from an oxygen source. The SMART BAG@MD is available in a child and an adult size. The SMART BAG@MD is available with components that can be autoclaved, or can be chemically disinfected. A single use disposable version is also available. The SMART BAG@Mo includes a flow limiting valve that limits the inspiratory flow to approximately 40 litres per minute, for the adult version and 30 litres per minute for the child version. The flow limiting valve is intended to minimize gastric inflation during manual ventilation. The flow limiting valve can be disabled to permit conventional operation of the resuscitator

Source page: https://510kreport.com/device/K021328
Methodology: https://510kreport.com/methodology