# K143615: Antistatic Compact Space Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Medical Developments International Limited
- Decided: Jan 26, 2016 after 403 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The antistatic Compact Space 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 device is intended for use in neonates, infants, children, adolescents and adults. The intended environments for use include home, hospitals and clinics.

Source page: https://510kreport.com/device/K143615
Methodology: https://510kreport.com/methodology