# K083693: PB 840 Ventilator System  with Leak Compensation Option, Model 840

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, Formerly Nellcor Puritan Bennett, Inc.
- Decided: Apr 2, 2009 after 111 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: 11 generations back to K902859 (1991). 72 ancestors in all.
6 later devices descend from it; 1 cites it directly.
11 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001646: Puritan-Bennett 840 Ventilator System with Neomode Option, Puritan Bennett Corp. (2000) Summary page 1.
- K073179: Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585, Maquet Critical Care AB (2008) Summary page 1.
- K070513: Hamilton-G5, Hamilton Medical AG (2007) Summary page 1.

## Most influential descendants
- K103211: Avea Ventilator (2011), 5 descendants of its own
- K131252: Puritan Bennett 980 Series Ventilator System (2014), 2 descendants of its own
- K162738: Puritan Bennett 980 Ventilator System (2017), 1 descendant of its own
- K162832: 731 Series Ventilators (2017), 1 descendant of its own
- K233486: 731 Series Ventilator (2024), 0 descendants of its own

## Indications for use
The 840 Ventilator System with Leak Compensation Option is intended to provide continuous ventilation to patients requiring respiratory support. The device is intended for patients with an Ideal Body Weight (IBW) as low as 0.5 kg (with NeoMode option) to adult, and for use in a wide variety of clinical conditions. The 840 Ventilator System with Leak Compensation Options is intended for a wide range of patients ranging from neonate to adult (VT 5-2500 mL with NecMode) or from infant to adult (VT 25-2500 mL). The 840 Ventilator System with Leak Compensation is intended for use in hospital and hospital-type facilities. It may be used during hospital and hospital-type facility transport provided that electrical power and compressed gas are supplied.

Source page: https://510kreport.com/device/K083693
Methodology: https://510kreport.com/methodology