# K912619: Bear 7 Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Bear Medical Systems, Inc.
- Decided: Jun 11, 1992 after 364 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.
176 later devices descend from it; 3 cite it directly.
49 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K970460: Nellcor Puritan Bennett, 840 Ventilator System (Model 840) (1998), 174 descendants of its own
- K983981: Bear 1000, Veolar W Leonardo Graphics, Bicore CP-2000, Bicore CP-100, HI-LO Jet ET Tube (1998), 134 descendants of its own
- 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

Source page: https://510kreport.com/device/K912619
Methodology: https://510kreport.com/methodology