# K983981: Bear 1000, Veolar W Leonardo Graphics, Bicore CP-2000, Bicore CP-100, HI-LO Jet ET Tube

- Pathway: 510(k) (Special)
- Applicant: Bear Medical Systems, Inc.
- Decided: Nov 20, 1998 after 11 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: 1 generation back to K900696 (1990). 3 ancestors in all.
134 later devices descend from it; 1 cites it directly.
41 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912619: Bear 7 Ventilator, Bear Medical Systems, Inc. (1992) Summary page 2.
- K935788: Bicore Smartcath Intratracheal Catheter, Bicore Monitoring Systems (1995) Summary page 2.
- K900696: Biore CP-100 Cardiopulmonary Monitor, Bicore Monitoring Systems (1990) Summary page 2.

## 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® 1000 Ventilator is fully capable of ventilating the entire spectrum of patients requiring such support-from the Emergency Room to the ICU, from pediatric patients to adults. The BEAR® 1000 Ventilator is available in a standard model as well as an upgraded model which includes the fully loaded enhancement package. The standard model BEAR™ 1000 Ventilator offers the clinician the following ventilatory modes: - Assist CMV - STMV (with or without Pressure Support), and - CPAP (with or without Pressure Support) In addition the Enhancement Package offers additional functions such as: - Pressure Control Ventilation - Minimum Minute Volume capability - Pressure Augmentation - Smart Trigger - ES (Esophageal Monitoring)

Source page: https://510kreport.com/device/K983981
Methodology: https://510kreport.com/methodology