# K981971: Tbird VS/Avs Volume Ventilator, Models 15568, 15570 , LP10 Volume Ventilator with Pressure Limit Model 00-004130, Bear 3

- Pathway: 510(k) (Traditional)
- Applicant: Bird Products Corp.
- Decided: Aug 24, 1998 after 81 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 K841279 (1984). 3 ancestors in all.
42 later devices descend from it; 2 cite it directly.
16 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950484: Tbird VS Ventilator and Tbird Avs Ventilator, Bird Products Corp. (1996) Summary page 2.
- K905244: Model LP6 Ventilator, Modification, Aequitron Medical, Inc. (1990) Summary page 2.
- K841279: BEAR 33, Bear Medical Systems, Inc. (1984) Summary page 2.

## Most influential descendants
- K984056: LTV 1000 (1999), 40 descendants of its own
- K022750: PLV Continuum Ventilator, Model P1000 (2003), 29 descendants of its own
- K083526: Trilogy 100 Ventilator (2009), 26 descendants of its own
- K093416: Trilogy 200 Ventilator (2010), 19 descendants of its own
- K070594: Palmtop Ventilator, Models PTV-8, PTV-10 (2007), 12 descendants of its own

## Indications for use
The TBird Homecare ventilator is intended to provide continuous or intermittent mechanical ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 Ibs.), who require the following general types of ventilatory support, as prescribed by an attending physician: Positive pressure ventilation Assist/Control, SIMV, CPAP modes of ventilation The ventilator is suitable for use in institutional and home settings.

Source page: https://510kreport.com/device/K981971
Methodology: https://510kreport.com/methodology