# K101348: Agachamber Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Aga Plastic Ind. Com. Ltda.
- Decided: Apr 29, 2011 after 351 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 K070674 (2007). 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)
- K070674: Aerochamber Plus Anti-Static Valved Holding Chamber with Flow-VU Inspiratory Flow Indicator, Trudell Medical Intl. (2007) Summary page 1.

## Indications for use
The AgaChamber Spacer is intended to be used by patients, who are under the care or treatment of a licensed healthcare provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or healthcare professional. The device has been developed for use, with or without mask, in accordance with necessity and medical orientation. The intended environments for use include home, hospitals and clinics.

Source page: https://510kreport.com/device/K101348
Methodology: https://510kreport.com/methodology