Cleared Traditional

K080230 - NEB-U-MASK SYSTEM

K080230 is an FDA 510(k) clearance for NEB-U-MASK SYSTEM, manufactured by Teleflexmedical, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K080230 · Teleflexmedical, Inc. · Anesthesiology device
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Jun 2008
Decision
131d
Days
Class 2
Risk

K080230 is an FDA 510(k) clearance for the NEB-U-MASK SYSTEM, MODELS 1895, 1896. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on June 9, 2008 after a review of 131 days - within the typical 510(k) review window.

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 Teleflexmedical, Inc. devices

FDA 510(k) Submission Details - K080230

510(k) Number K080230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2008
Decision Date June 09, 2008
Days to Decision 131 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
9d faster than avg
Panel avg: 140d · This submission: 131d
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 223
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K080230.
ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210
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ULTRASONIC NEBULIZER SYSTEM, MODEL HL100
K081738 · Health & Life Co., Ltd. · Sep 2008
AMSURE NEBULIZER
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K072119 · Cardinalhealth · Aug 2007
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