# K080969: Healthline Redi-Neb Medication Nebulizer, Model RN-510

- Pathway: 510(k) (Traditional)
- Applicant: Medi Nuclear Corp., Inc.
- Decided: Jul 25, 2008 after 112 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: 2 generations back to K870027 (1987). 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)
- K915075: Nebulizer (Direct Patient Interface), Medi Nuclear Corp., Inc. (1992) Summary page 1.
- K962879: Salterlabs 8660 Series Nebulizer, Salter Labs (1996) Summary page 1.

## Indications for use
The Healthline RediNeb® Small Volume Medication Nebulizer (SVN) is indicated to aerosolize medication approved for nebulization by a physician. The Healthline RediNeb® Medication Nebulizer is intended for adult and pediatric patients consistent with the indications for aerosolized medication to or through the patient's pulmonary system. The RediNeb® Nebulizer device is for patient use in all areas where the administration of medication by aerosol means is warranted. This includes hospital/institutional settings, home care use, schools and long term care facilities.

Source page: https://510kreport.com/device/K080969
Methodology: https://510kreport.com/methodology