# K001646: Puritan-Bennett 840 Ventilator System with Neomode Option

- Pathway: 510(k) (Traditional)
- Applicant: Puritan Bennett Corp.
- Decided: Oct 20, 2000 after 143 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
112 later devices descend from it; 5 cite it directly.
36 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022132: Servo Ventilator System, Model 64 87 800 E407E (2002), 102 descendants of its own
- K040221: Servo-I Ventilator System, Model 64 87 800 E407E (2004), 75 descendants of its own
- K041223: Modification to Servo-I Ventilator System, Model 64 87 800 E407E (2004), 73 descendants of its own
- K063404: Servo-I Ventilator System, Models 64, 87 and 800 (2007), 61 descendants of its own
- K040574: Galileo Gold (2004), 53 descendants of its own

## Recalls of this device
- Dec 16, 2013 · Class I · Z-0611-2014: Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB006

Source page: https://510kreport.com/device/K001646
Methodology: https://510kreport.com/methodology