# K020944: Vortex Valved Holding Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Pari Innovative Manufacturers, Inc.
- Decided: May 9, 2002 after 45 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 K822437 (1982). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992917: Aerochamber Plus Valved Holding Chamber, Trudell Medical Int'L (1999) Summary page 1.
- K930574: Aerochamber W/Mask, Modified, Monaghan Medical Corp. (1994) Summary page 1.
- K900576: Modified Aerochamber with Mask, Monaghan Medical Corp. (1991) Summary page 1.
- K900557: Modified Aerochamber M.V. Aerosol Holding Chamber, Monaghan Medical Corp. (1991) Summary page 1.
- K884803: Aerochamber M.V., Monaghan Medical Corp. (1989) Summary page 1.
- K872037: Aerochamber, Monaghan Medical Corp. (1987) Summary page 1.
- K822437: Monaghan Aerochamber, Monaghan Medical Corp. (1982) Summary page 1.

## Indications for use
Vortex is indicated for use as a spacer/valved holding chamber for use in delivery of aerosol medication with metered dose inhalers.

Source page: https://510kreport.com/device/K020944
Methodology: https://510kreport.com/methodology