Cleared Traditional

K080100 - WATCHHALER

K080100 is an FDA 510(k) clearance for WATCHHALER, manufactured by Activaero America, Inc.. The device is a Class 2 Anesthesiology device with product code NVP cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K080100 · Activaero America, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
168d
Days
Class 2
Risk

K080100 is an FDA 510(k) clearance for the WATCHHALER. Classified as Holding Chambers, Direct Patient Interface (product code NVP), Class II - Special Controls.

Submitted by Activaero America, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on June 30, 2008 after a review of 168 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K080100

510(k) Number K080100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2008
Decision Date June 30, 2008
Days to Decision 168 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 140d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NVP Device Classification - Class 2, Special Controls

Product Code NVP Holding Chambers, Direct Patient Interface
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
Definition 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 Inhales The Dispensed Medication. Holding Chambers Are Intended To Minimize Delivery Of Large Aerosolized Particles
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - NVP Holding Chambers, Direct Patient Interface

All 15
Devices cleared under the same product code (NVP) and FDA review panel - the closest regulatory comparables to K080100.
AGACHAMBER SPACER
K101348 · Aga Plastic Ind. Com. Ltda. · Apr 2011
RESPICHAMBER VALVED HOLDING CHAMBER
K110136 · Trudell Medical Intl. · Apr 2011
FISIO CHAMBER SPACE
K101136 · Koo (Shanghai) Industries Co., Ltd. · Jan 2011
AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR
K070674 · Trudell Medical Intl. · Apr 2007
AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER
K052332 · Trudell Medical Intl. · Sep 2005