510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080100Substantially Equivalent

Watchhaler

Activaero America, Inc., Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080100 is the FDA 510(k) clearance record for WATCHHALER, a class II device, cleared for Activaero America, Inc. 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 3 510(k) clearances for Activaero America, Inc., from to . As of , FDA records show no recalls naming K080100.

Clearance record

Decision date
Received
(168 days to decision)
Product code
NVP Holding Chambers, Direct Patient Interface
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Activaero America, Inc. 24301 Woodsage Dr., Bonita Springs FL
510(k) summary
Summary PDF
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