# K993071: Puritan-Bennett Ventilator System with ET/Tracheostomy Tube Compensation, TC, Option, Model 840

- Pathway: 510(k) (Special)
- Applicant: Puritan Bennett Corp.
- Decided: Nov 24, 1999 after 71 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: 2 generations back to K902859 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902506: 7200AE Microprocessor Ventilator W/Enhanced Hard., Puritan Bennett Corp. (1991) Summary page 1.
- K961687: EVITA 4, Drager, Inc. (1996) Summary page 1.

## 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 ET/Tracheostomy Tube Compensation, TC, 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.

Source page: https://510kreport.com/device/K993071
Methodology: https://510kreport.com/methodology