# K964719: Hudson Rci Lifesaver Single Patient Use Manual Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Hudson Respiratory Care, Inc.
- Decided: Feb 21, 1997 after 88 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911465 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911465: Infant/Pediatric Resuscitation Circuit W/Apl, Vital Signs, Inc. (1991) Summary page 1.

## Recalls of this device
- May 14, 2015 · Class I · Z-1809-2015: The intake port may be blocked which can cause the bag to fail to fill.

## Indications for use
The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator with pressure monitoring port is disposable medical device intended for use on patients requiring temporary augmentation of ventilation, with or without supplemental oxygen delivery, during episode of acute ventilatory failure or insufficiency, who, because of their weight or other factors, require monitoring of peak inspiratory pressure. The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator provides a means of temporary ventilation until the patient either regains the ability to spontaneously ventilate, or until other life sustaining measures may be implemented. Resuscitators may also be used as a “back-up” ventilation system in the event of mechanica! ventilator failure, or may be used to hyper oxygenate or hyperventilate a patient prior to endotracheal tube suctioning or endotracheal intubation. The pressure monitoring port component of the device permits the monitoring of peak inspiratory pressures in those patients where PIP is a concern.

Source page: https://510kreport.com/device/K964719
Methodology: https://510kreport.com/methodology