# K110136: Respichamber Valved Holding Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Trudell Medical Intl.
- Decided: Apr 18, 2011 after 90 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 K962822 (1996). 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)
- K962822: Optichamber, Healthscan Products, Inc. (1996) Summary page 1.

## Indications for use
The RespiChamber Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care 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 health care professional. The intended environments for use include the home, hospitals and clinics.

Source page: https://510kreport.com/device/K110136
Methodology: https://510kreport.com/methodology