# K101136: Fisio Chamber Space

- Pathway: 510(k) (Traditional)
- Applicant: Koo (Shanghai) Industries Co., Ltd.
- Decided: Jan 28, 2011 after 281 days
- Product code: NVP (Holding Chambers, 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 K010680 (2001). 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)
- K010680: CT Spacer, Clinical Technologies, Inc. (2001) Summary page 3.
- K070674: Aerochamber Plus Anti-Static Valved Holding Chamber with Flow-VU Inspiratory Flow Indicator, Trudell Medical Intl. (2007) Summary page 3.

## Indications for use
The Fisio Chamber Spacer is intended to be used by patients who are under the care of treatment of a licensed healthcare professional or physician. The device is intended to be used by these patients to administer aerosolized medication from pressurized Metered-Dose Inhalers, prescribed by a physician or healthcare professional.

Source page: https://510kreport.com/device/K101136
Methodology: https://510kreport.com/methodology