# K984535: Puritan-Bennett 840 Ventilatory System with Bilevel Option

- Pathway: 510(k) (Special)
- Applicant: Puritan Bennett Corp.
- Decided: Dec 28, 1998 after 7 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
Longest line of descent: 3 generations back to K902859 (1991). 7 ancestors in all.
55 later devices descend from it; 3 cite it directly.
21 of 63 devices in its family (counting itself) have 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.
- K902506: 7200AE Microprocessor Ventilator W/Enhanced Hard., Puritan Bennett Corp. (1991) Summary page 1.
- K961687: EVITA 4, Drager, Inc. (1996) Summary page 1.
- K902859: Servo Ventilator 300, Siemens Life Support Systems (1991) Summary page 1.

## Most influential descendants
- K022679: Raphael (2003), 54 descendants of its own
- K040574: Galileo Gold (2004), 53 descendants of its own
- 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

## 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

## Indications for use
The 840 Ventilator System with BiLevel Option is used to provide continuous ventilation to patient’s 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.

Source page: https://510kreport.com/device/K984535
Methodology: https://510kreport.com/methodology