# K972203: Babybird Ventilator, Portable Lifecare Ventilator, External Pressure Limiter, Volume Ventilator with Pressure Limit

- Pathway: 510(k) (Traditional)
- Applicant: Allied Healthcare Products, Inc.
- Decided: Nov 6, 1997 after 148 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The BEAR Adjustable Pressure Limit Valve is intended to be an accessory for the BEAR 33 Volume Ventilator which provides clinically accepted features for the ventilation management of pediatric patients requiring breath volume delivery of 100 ml to 2200 ml. In addition to the standard features, the intent of this device is to be utilized during high flow and high tidal volume delivery to those patients with an uncuffed artificial airway or in other patient configurations which ensure an intentional artificial airway leak. The pressure relief valve is intended to be used with patients that have respiratory failure/insufficiency and require mechanical ventilation.

Source page: https://510kreport.com/device/K972203
Methodology: https://510kreport.com/methodology