# K990897: Nellcor Puritan Bennett 700 Series Ventilator System, and Easyneb Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Puritan-Bennett Ireland, Ltd.
- Decided: Mar 15, 2000 after 363 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902859 (1991). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902859: Servo Ventilator 300, Siemens Life Support Systems (1991) Summary page 1.
- K960854: Siemens Servo Ultra Nebulizer 345, Pacesetter, Inc. (1996) Summary page 1.

## Most influential descendants
- K041082: Newport Nebsonic N550 Ultrasonic Nebulizer (2004), 0 descendants of its own
- K020357: 800 Series Easyneb Nebulizer (2002), 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

## Indications for use
The 700 Series 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. It also has the capability to provide nebulization through use of an optional accessory, the EasyNeb Nebulizer.

Source page: https://510kreport.com/device/K990897
Methodology: https://510kreport.com/methodology