# K021573: Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus Option

- Pathway: 510(k) (Special)
- Applicant: Puritan-Bennett
- Decided: Aug 13, 2002 after 91 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: 3 generations back to K902859 (1991). 6 ancestors in all.
52 later devices descend from it; 2 cite it directly.
19 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902859: Servo Ventilator 300, Siemens Life Support Systems (1991) Summary page 1.
- K961687: EVITA 4, Drager, Inc. (1996) Summary page 1.
- K970165: Evita 2 Dura, Drager, Inc. (1997) Summary page 1.
- K001686: Galileo Ventilator, Hamilton Medical, Inc. (2000)

## Most influential descendants
- K051263: Evitaxl with Option Smartcare (2005), 51 descendants of its own
- K061090: Galileo Gold Asv (2006), 36 descendants of its own
- K070513: Hamilton-G5 (2007), 26 descendants of its own
- K072412: Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models 8415941, 8415942, 6871500 (2008), 23 descendants of its own
- K080181: Modification to Galileo Gold (2008), 21 descendants of its own

## Indications for use
The 840 Ventilator with Volume Ventilation PlusT"Option is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from infant to adult and for a wide variety of clinical conditions. The 840 Ventilator with Neomode and Volume Ventilation Plu? Options provides continuous ventilation to patients requiring respiratoroy support. The Neomode Option, which is used on neonatal patients with Ideal Body Weights (IBW) as low as 0.5kg, is intended to cover a variety of clinical conditions. The 840 Ventilatory with Neomode and Volume Ventilation Plus Options is intended for use in hospitals 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/K021573
Methodology: https://510kreport.com/methodology