Pocket Chamber Valved Aerosol Holding Chamber
by Ferraris Medical, Inc. 510(k)
Active
510(k) K993199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993199 | Date28 Mar 2000 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CAF
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5630
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Pocket Chamber Valved Aerosol Holding Chamber is a cylindrical valved aerosol holding chamber (spacer) used to facilitate medication delivery from metered-dose inhaler (MDI) canisters. It features a cylindrical tube approximately 3.1 inches long by 4.5 cm wide with an MDI receptacle designed to prevent off-center actuations and a one-way valve located between the chamber and the patient interface.
The device is classified as a Nebulizer (direct Patient Interface) under product code CAF, Class II with Special Controls. It received FDA 510(k) clearance (K993199) on March 28, 2000, following a traditional review process. The device is supplied non-sterile and is intended for reusable use in patient care settings.
Other devices from Ferraris Medical, Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the Pocket Chamber Valved Aerosol Holding Chamber used for?
It is used to facilitate medication delivery from metered-dose inhaler (MDI) canisters by acting as a valved aerosol holding chamber (spacer) that helps coordinate inhalation with medication release, improving lung deposition and reducing oropharyngeal deposition.
How is the Pocket Chamber Valved Aerosol Holding Chamber supplied and is it reusable?
The device is supplied non-sterile and is intended for reusable use in patient care settings, meaning it can be cleaned and used multiple times according to the manufacturer's instructions for cleaning and maintenance.
What are the key design features of the Pocket Chamber Valved Aerosol Holding Chamber?
It features a cylindrical tube approximately 3.1 inches long by 4.5 cm wide, an MDI receptacle designed to prevent off-center actuations, and a one-way valve located between the chamber and the patient interface to ensure unidirectional airflow during inhalation and exhalation.