# K970460: Nellcor Puritan Bennett, 840 Ventilator System (Model 840)

- Pathway: 510(k) (Traditional)
- Applicant: Puritan Bennett Corp.
- Decided: Apr 30, 1998 after 448 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 8 (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). 6 ancestors in all.
174 later devices descend from it; 7 cite it directly.
49 of 181 devices in its family (counting itself) have 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.
- K912619: Bear 7 Ventilator, Bear Medical Systems, Inc. (1992) Summary page 1.
- K902859: Servo Ventilator 300, Siemens Life Support Systems (1991) Summary page 1.
- K961687: EVITA 4, Drager, Inc. (1996) Summary page 1.

## Most influential descendants
- K013642: AVEA (2002), 133 descendants of its own
- K032451: Bird Tbird Vela Ventilator (2004), 114 descendants of its own
- K052554: Modification to: Ivent 201 Portable Ventilator (2005), 112 descendants of its own
- K053270: IVENT 201 (2006), 87 descendants of its own
- K061627: Modification to I Vent 201 (2006), 86 descendants of its own

## Recalls of this device
- Jun 4, 2014 · Class II · Z-1809-2014: In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator continues to provide uninterrupted ventilatory support at the programmed settings for the patient. However
- Jun 3, 2014 · Class II · Z-1844-2014: Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators due to customer reports of loss of graphical user interface (GUI) display information while the ve
- 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
- Jan 25, 2013 · Class II · Z-0822-2014: Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett" 840, and PN, G-062010-00, used in Puritan Bennett" 740, an
- Jan 25, 2013 · Class II · Z-0821-2014: Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett" 840, and PN, G-062010-00, used in Puritan Bennett" 740, an
- Mar 21, 2008 · Not classified · Z-1692-2008: Wiring in battery back-up power supply may short and cause thermal damage to ventilator.
- Mar 12, 2007 · Not classified · Z-0760-2007: In rare instances, the safety valve may remain open after an occlusion is resolved. If the safety valve does not reset, the ventilator will detect a circuit disconnect condition. When this happens, th
- Apr 20, 2005 · Not classified · Z-1085-05: Manufacturing defect at contract manufacturer, employee error, poor training, improper inspection.

## Indications for use
The 840 Ventilator System 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/K970460
Methodology: https://510kreport.com/methodology