# K082092: Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable Fixed Peep Valve

- Pathway: 510(k) (Traditional)
- Applicant: Galemed Corp.
- Decided: Oct 15, 2008 after 83 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: 1 generation back to K902062 (1990). 2 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944301: Hudson Rci Lifesaver Single Patient Use Manual Resuscitator Catalog Numbers: 5360 Through 5380, Hudson Respiratory Care, Inc. (1994) Summary page 1.
- K902062: Peep Valve, Hudson Oxygen Therapy Sales Co. (1990) Summary page 1.

## Most influential descendants
- K170663: Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer (2018), 1 descendant of its own
- K090317: Babi*Plus Bubble Pap Valve (2009), 1 descendant of its own
- K210288: Disposable Manual Resuscitator (2021), 0 descendants of its own
- K133957: Disposable Adjustable Peep Valve MR Conditional Use (2014), 0 descendants of its own
- K112852: Babi Plus Neonatal Resuscitation Bag (2012), 0 descendants of its own

## Indications for use
Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: < 10Kg, Child: - 23 Kg, Adult: >23 Kg Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: - 10 Kg, Child: - 23 Kg, Adult: > 23 Kg This manual resuscitator is supplied with a single patient use positive end expiratory pressure (PEEP) valve for use hospital, transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions. Single patient use positive end expiratory pressure (PEEP) valve for use hospital, transport, emergency. and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions.

Source page: https://510kreport.com/device/K082092
Methodology: https://510kreport.com/methodology