Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K143615Substantially Equivalent

Antistatic Compact Space Chamber

Medical Developments International, Springvale, AU / Traditional, Substantially Equivalent

K143615 is the FDA 510(k) clearance record for Antistatic Compact Space Chamber, a class II device, cleared for Medical Developments International Limited on under FDA product code NVP (Holding Chambers, Direct Patient Interface). FDA's definition for product code NVP reads: "Holding chambers are devices that are used with nebulizers and metered dose inhalers and are comprised of a reservoir into which an aerosol medication is dispensed. A holding chamber uses a valved mouthpiece through which the patient...". FDA records list 2 510(k) clearances for Medical Developments International Limited, from to . As of , FDA records show no recalls naming K143615.

Clearance record

Decision date
Received
(403 days to decision)
Product code
NVP Holding Chambers, Direct Patient Interface
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Medical Developments International Limited 7/56 Smith Rd., Springvale, AU
510(k) summary
Statement
Third party review
No

Clearances, product code NVP

Trailing 12 months

FDA records hold no clearances under product code NVP in the trailing twelve months.

FDA records show no clearances under product code NVP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NVP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260