Cleared Traditional

K162041 - Airworks Nebulizer pe1200m

K162041 is an FDA 510(k) clearance for Airworks Nebulizer pe1200m, manufactured by Convexity Scientific, LLC. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K162041 · Convexity Scientific, LLC · Anesthesiology device
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May 2017
Decision
281d
Days
Class 2
Risk

K162041 is an FDA 510(k) clearance for the Airworks Nebulizer pe1200m. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Convexity Scientific, LLC (Westport, US). The FDA issued a Cleared decision on May 2, 2017 after a review of 281 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.

View all Convexity Scientific, LLC devices

FDA 510(k) Submission Details - K162041

510(k) Number K162041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2016
Decision Date May 02, 2017
Days to Decision 281 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 140d · This submission: 281d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 224
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K162041.
SmartTouch
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HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML
K142153 · Teleflexmedical, Inc. · Apr 2015