510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K070674Substantially Equivalent

Aerochamber Plus Anti-Static Valved Holding Chamber with Flow-Vu Inspiratory Flow Indicator

Trudell Medical Intl., London, CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K070674 is the FDA 510(k) clearance record for AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR, a class II device, cleared for Trudell Medical Intl. 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 15 510(k) clearances for Trudell Medical Intl., from to . As of , FDA records show no recalls naming K070674.

Clearance record

Decision date
Received
(30 days to decision)
Product code
NVP Holding Chambers, Direct Patient Interface
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Trudell Medical Intl. 725 Third St., London, CA
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