# K092847: 840 Ventilator System with Expanded Neomode Option

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, Formerly Nellcor Puritan Bennett, Inc.
- Decided: Mar 11, 2010 after 176 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). 24 ancestors in all.
11 later devices descend from it; 2 cite it directly.
9 of 36 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)
- K081837: Avea Ventilator, Cardinal Health 207, Inc. (2008) Summary page 2.

## Most influential descendants
- K151252: Puritan Bennett 840 Series Ventilator System (2016), 7 descendants of its own
- K181166: Trilogy Evo (2019), 5 descendants of its own
- K193586: Vivo 45 LS (2021), 2 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

## Indications for use
The 840 Ventilator System with Expanded NeoMode Option provides continuous ventilation to patients requiring respiratory support. The 840 Ventilator System with Expanded NeoMode Option, is intended for patients with an Ideal Body Weight (IBW) as low as 0.3 kg and for use in a wide variety of clinical conditions. The 840 Ventilator System with Expanded NeoMode Option 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/K092847
Methodology: https://510kreport.com/methodology