# K140062: FSC Anti-Static Valved Collapsible Holding Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Fsc Laboratories, Inc.
- Decided: Oct 3, 2014 after 266 days
- Product code: NVP (Holding Chambers, Direct Patient Interface)
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933090 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052332: Aerochamber Z-Stat Plus Valved Holding Chamber, Trudell Medical Intl. (2005) Summary page 5.
- K933090: EZ-Spacer, Airpharma, LLC (1994) Summary page 5.

## Recalls of this device
- May 16, 2016 · Class II · Z-1995-2016: Product had torn/loose seal around the mouthpiece.

## Indications for use
The FSC Anti-Static Valved Collapsible Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. (pMDIs). Environment of use - Home, hospitals and clinics. This product is intended for patients who can follow verbal instructions.

Source page: https://510kreport.com/device/K140062
Methodology: https://510kreport.com/methodology