# K020357: 800 Series Easyneb Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Aug 7, 2002 after 184 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- 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). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990897: Nellcor Puritan Bennett 700 Series Ventilator System, and Easyneb Nebulizer, Puritan-Bennett Ireland, Ltd. (2000) 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 800 Series EasyNeb is intended to serve as an accessory to the Puritan Bennett Model 840 Ventilator to provide nebulization of medications.

Source page: https://510kreport.com/device/K020357
Methodology: https://510kreport.com/methodology