# K032809: Hospital Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Healthscan, Inc.
- Decided: Nov 13, 2003 after 65 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 K992917 (1999). 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)
- K992917: Aerochamber Plus Valved Holding Chamber, Trudell Medical Int'L (1999) Summary page 1.

## Indications for use
ProChamberTMValved Holding Chamber is intended for use in combination with Metered Dose Inhalers (MDl’s) to assist in respiratory drug delivery. All patients using MDl’s, i.e., children and adults, may use Prochamber T’. Settings for use include the home, clinics and hospitals. This device is intended for prescription use.

Source page: https://510kreport.com/device/K032809
Methodology: https://510kreport.com/methodology