# K984379: Nellcor Puritan Bennett, 760 Ventilator System

- Pathway: 510(k) (Special)
- Applicant: Puritan Bennett Corp.
- Decided: Dec 10, 1998 after 3 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 4 (0 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). 9 ancestors in all.
8 later devices descend from it; 2 cite it directly.
2 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964540: Nellcor Puritan Bennett, 740 Ventilator System, Puritan Bennett Corp. (1997) Summary page 1.
- K902506: 7200AE Microprocessor Ventilator W/Enhanced Hard., Puritan Bennett Corp. (1991) Summary page 1.
- K970460: Nellcor Puritan Bennett, 840 Ventilator System (Model 840), Puritan Bennett Corp. (1998) Summary page 1.

## Most influential descendants
- K021112: Inspiration Ventilator System (2002), 6 descendants of its own
- K030341: Modification to Inspiration Ventilator System (2004), 4 descendants of its own
- K051550: Inspiration Ventilator System (2005), 3 descendants of its own
- K072590: Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System and Infant LS Ventilator System (2008), 2 descendants of its own
- K130178: Inspiration Ventilator System 5I/7I (2013), 0 descendants of its own

## Recalls of this device
- 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
- Dec 17, 2004 · Not classified · Z-0445-05: Capacitor weakness in backup alarm system might fail causing lack of backup alarm to function in the event of total power loss.
- Dec 16, 2004 · Not classified · Z-0444-05: Wires on battery may loosen causing disconnection.

## Indications for use
The 760 Ventilator System is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from pediatric to adult and for a wide variety of clinical conditions.

Source page: https://510kreport.com/device/K984379
Methodology: https://510kreport.com/methodology