# K110293: Optichamber Diamond Valved Holding Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Respironics New Jersey, Inc.
- Decided: Aug 9, 2011 after 189 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 K052332 (2005). 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)
- K052332: Aerochamber Z-Stat Plus Valved Holding Chamber, Trudell Medical Intl. (2005) Summary page 2.

## Recalls of this device
- Mar 16, 2021 · Class II · Z-1941-2021: Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

## Indications for use
The OptiChamber Diamond Valved Holding Chamber device is intended to be used by patients who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose inhalers. The intended environments for use include the home, hospitals and clinics. For Single Patient Use Recommended Patient Population: OptiChamber Diamond: Age 5 and up OptiChamber Diamond with Small LiteTouch mask: 0 to 18 months OptiChamber Diamond with Medium LiteTouch mask: 1 to 5 years OptiChamber Diamond with Large LiteTouch mask: 5 years +

Source page: https://510kreport.com/device/K110293
Methodology: https://510kreport.com/methodology