# K992788: Bear Cub 750 PSV

- Pathway: 510(k) (Special)
- Applicant: Bear Medical Systems, Inc.
- Decided: Sep 16, 1999 after 28 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
Longest line of descent: 3 generations back to K902859 (1991). 6 ancestors in all.
134 later devices descend from it; 1 cites it directly.
41 of 141 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970839: Servo Ventilator 300A, Siemens Elema AB (1997) Summary page 1.
- K895541: V.I.P. Bird Infant - Pediatric Ventilator, Bird Products Corp. (1990) Summary page 1.
- K974176: Babylog 8000 Plus, Drager, Inc. (1998) Summary page 1.

## Most influential descendants
- K013642: AVEA (2002), 133 descendants of its own
- K032451: Bird Tbird Vela Ventilator (2004), 114 descendants of its own
- K052554: Modification to: Ivent 201 Portable Ventilator (2005), 112 descendants of its own
- K053270: IVENT 201 (2006), 87 descendants of its own
- K061627: Modification to I Vent 201 (2006), 86 descendants of its own

## Indications for use
The BEAR CUB 750 PSV Infant Ventilator is intended to provide ventilatory support for a patient population ranging from the small neonate 500 grams and larger to a small pediatric patient up to 30 kilograms.

Source page: https://510kreport.com/device/K992788
Methodology: https://510kreport.com/methodology