# K072418: Optichamber Advantage Anti-Static Valved Holding Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Respironics New Jersey, Inc.
- Decided: Sep 12, 2007 after 15 days
- Product code: CAF (Nebulizer (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). 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). Our reading of the summary gave K052322, FDA’s number for Bard Collamend Implant, Models 1175101, 1175102, 1175103… (C.R. Bard, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “AeroChamber Z-Stat Plus Valved Holding Chamber”. Summary page 2.
- K962822: Optichamber, Healthscan Products, Inc. (1996) Summary page 3.

## Indications for use
OptiChamber Advantage Anti-Static Valved Holding Chamber is intended to be used in combination with Metered Dose Inhalers (MDIs) for respiratory drug delivery. This device, as is the case with other spacer devices, is intended to leave larger non-respirable drug particles within the device and allows smaller respirable particles to be delivered to the lungs.

Source page: https://510kreport.com/device/K072418
Methodology: https://510kreport.com/methodology