# K053203: Myneb Nebulizer, Model RDD100

- Pathway: 510(k) (Traditional)
- Applicant: Respironics New Jersey, Inc.
- Decided: Dec 20, 2005 after 34 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 K935540 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990506: Mabis NB-02 Ultrasonic Nebulizer, Mabis Healthcare, Inc. (1999) Summary page 1.
- K960675: Walkhaler Portable Compressor Model 45F70, Pari Holding Co. (1996) Summary page 1.
- K935540: Pari-Master Modification, Pari Holding Co. (1995) Summary page 1.

## Indications for use
MyNeb is an AC or battery-pack powered nebulizer designed to convert liquid medication into aerosol for inhalation by the patient.

Source page: https://510kreport.com/device/K053203
Methodology: https://510kreport.com/methodology