# K170663: Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer

- Pathway: 510(k) (Traditional)
- Applicant: Foremount Enterprise Co., Ltd.
- Decided: May 11, 2018 after 431 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: 2 generations back to K902062 (1990). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082092: Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable Fixed Peep Valve, Galemed Corp. (2008) Summary page 4.
- K122077: Manometer, Intersurgical, Inc. (2013) Summary page 4.

## Most influential descendants
- K210288: Disposable Manual Resuscitator (2021), 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: less than or equal to 10Kg, Child: less than or equal to 23 Kg, Adult: greater than 23 Kg This manual resuscitator may be supplied with a single patient use positive end expiratory pressure (PEEP) valve and / or disposable Airway Pressure Manometer. The PEEP Valve is 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. Intended for patients that the clinician has determined need PEEP. The Disposable Manometer is a single patient use manometer intended to be used for monitoring the patient’s airway pressure during ventilation. The manometer is to be used with resuscitation systems.

Source page: https://510kreport.com/device/K170663
Methodology: https://510kreport.com/methodology