# K082541: Healthline Medicator / Redineb Aerosol Drug Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Medi Nuclear Corp., Inc.
- Decided: Nov 26, 2008 after 85 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 K963924 (1996). 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)
- K061381: LC Star with Nasal Adapter, Pari Innovative Manufacturers, Inc. (2006) Summary page 1.
- K963924: LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70, Pari Holding Co. (1996) Summary page 1.

## Indications for use
MEDICATOR®/RediNeb® Aerosol Drug Delivery System is indicated to aerosolize medication approved for nebulization and prescribed by a physician. This Healthline medication nebulizer device is intended for adult and pediatric patients consistent with the indications for delivery of aerosolized medication to-or-through the patient's pulmonary system. The MEDICATOR®/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/K082541
Methodology: https://510kreport.com/methodology