# K151252: Puritan Bennett 840 Series Ventilator System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien LP
- Decided: Mar 29, 2016 after 322 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: 7 generations back to K902859 (1991). 25 ancestors in all.
7 later devices descend from it; 2 cite it directly.
6 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092847: 840 Ventilator System with Expanded Neomode Option, Covidien, Formerly Nellcor Puritan Bennett, Inc. (2010) Summary page 4.

## Most influential descendants
- K181166: Trilogy Evo (2019), 5 descendants of its own
- K193586: Vivo 45 LS (2021), 2 descendants of its own
- K232365: Vivo 45 LS (2025), 0 descendants of its own
- K233452: Vivo 45 LS (2025), 0 descendants of its own
- K241135: RESPOND (R) Ventilator (2024), 0 descendants of its own

## Indications for use
The 840 Series Ventilator is intended to provide 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. The 840 Series Ventilator 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/K151252
Methodology: https://510kreport.com/methodology