# K970035: John Bunn Neb-U-Lite II Medication Compressor with Disposable Nebulizer, Model #Jbo-112-009

- Pathway: 510(k) (Traditional)
- Applicant: Graham-Field, Inc.
- Decided: Apr 1, 1997 after 88 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931015 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931015: Devilbiss Model 4650 Compressor Neubulizer, Devilbiss Health Care, Inc. (1993) Summary page 1.

## Indications for use
This nebulizer compressaor is an AC-powered air combressor intended to provide a source of compressed air for medical purposes for use in home health care. This device is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders such as asthma, allergies, etc.

Source page: https://510kreport.com/device/K970035
Methodology: https://510kreport.com/methodology