# K063650: Ventilator with Respiratory Mechanics, Model 840

- Pathway: 510(k) (Special)
- Applicant: Puritan Bennett Corp.
- Decided: Feb 15, 2007 after 69 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: 4 generations back to K902859 (1991). 19 ancestors in all.
No later device cites it as a predicate yet.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970460: Nellcor Puritan Bennett, 840 Ventilator System (Model 840), Puritan Bennett Corp. (1998) Summary page 1.
- K984379: Nellcor Puritan Bennett, 760 Ventilator System, Puritan Bennett Corp. (1998) Summary page 1.
- K930017: PB 7200 Series Ventilatory System W/Keyboard, Puritan Bennett Corp. (1994) Summary page 1.
- K922654: Ventilator Adult Star Modification, Infrasonics Corp. (1992) Summary page 1.
- K062093: Avea Ventilator, Viasys Respiratory Care, Inc. (2006) Summary page 1.

## Indications for use
The 840 Ventilator with Respiratory Mechanics 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 with Respiratory Mechanics Options is intended for a wide range of patients ranging from neonate to adult (VT 5-2500 mL with NeoMode) or from infant to adult (VT 2 5 -2 50 0 mnL) The 840 Ventilator with Respiratory Mechanics 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/K063650
Methodology: https://510kreport.com/methodology