# K070899: Puritan Bennett Legendair XL2

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett
- Decided: Dec 13, 2007 after 255 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K902859 (1991). 15 ancestors in all.
8 later devices descend from it; 3 cite it directly.
2 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003770: Bird Tbird Legacy Ventilator, Bird Products Corp. (2000) Summary page 1.
- K051767: LTV 1000 Ventilator, Pulmonetic Systems, Inc. (2005)

## Most influential descendants
- K082982: Breathe Technologies Ventilator and Accessories (2009), 5 descendants of its own
- K100528: Breathe Technologies Ventilator and Accessories BT-V2S (2010), 4 descendants of its own
- K102525: Breathe Technologies Ventilator and Accessories (BT-V2S) (2010), 3 descendants of its own
- K103345: Breathe Technologies Ventilator and Accessories (BT-V2S) (2011), 2 descendants of its own
- K131562: Breathe Niov Ventilation System (2014), 1 descendant of its own

## Recalls of this device
- Jun 24, 2024 · Class I · Z-2446-2024: Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one ventilator over time, the use of these devi

## Indications for use
The Legendair XL2 is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 5 kg 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 who require the following general types of ventilatory support, as prescribed by an attending physician: • Positive Pressure ventilation * Assist/Control, SIMV, or CPAP modes of ventilation * Breath types including Volume, Pressure Control and Pressure Support. The ventilator is suitable for use in institutional, home, and transport settings. It is not intended for use as an emergency transport ventilator.

Source page: https://510kreport.com/device/K070899
Methodology: https://510kreport.com/methodology