# K053388: Model 840 Ventilator with Proportional Assist Ventilation Plus Software Option

- Pathway: 510(k) (Traditional)
- Applicant: Puritan Bennett Corp.
- Decided: Apr 4, 2006 after 120 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: 7 generations back to K902859 (1991). 27 ancestors in all.
6 later devices descend from it; 2 cite it directly.
4 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021573: Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus Option, Puritan-Bennett (2002) Summary page 1.
- K051263: Evitaxl with Option Smartcare, Drager Medical AG & Co. Kgaa (2005) Summary page 1.

## Most influential descendants
- K103578: Philips NM3 Respiratory Monitor with Ventassist (2011), 4 descendants of its own
- K222897: Enlight 2100 (2023), 2 descendants of its own
- K250464: Enlight 2100 (TPL-E2103-0) (2025), 0 descendants of its own
- K243765: LuMon (TM) System (2025), 0 descendants of its own
- K192584: BEACON Caresystem Model 00002144 (2019), 0 descendants of its own

## Recalls of this device
- Dec 16, 2013 · Class I · Z-0611-2014: Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB006

## Indications for use
The Puritan Bennett 840 ventilator with Proportional Assist Ventilation® Plus (PAV+) software option is intended for use in spontaneously breathing adult patients whose ventilator ideal body weight (JEW) is at least 25.0 kg. Patients must be intubated with either endotracheal or tracheostomy tubes of internal diameter of 6.0 mm to 10.0 mm. Patients must have satisfactory neural-ventilatory coupling, and stable, sustainable inspiratory drive. PAV+ is intended for use in hospitals and hospital-type facilities.

Source page: https://510kreport.com/device/K053388
Methodology: https://510kreport.com/methodology