# K082966: PB 540 Ventilator

- Pathway: 510(k) (Special)
- Applicant: Covidien, Formerly Nellcor Puritan Bennett, Inc.
- Decided: Oct 31, 2008 after 25 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: 6 generations back to K902859 (1991). 16 ancestors in all.
No later device cites it as a predicate yet.
2 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070899: Puritan Bennett Legendair XL2, Nellcor Puritan Bennett (2007) Summary page 2.

## Indications for use
The PB 540 Ventilator 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/K082966
Methodology: https://510kreport.com/methodology