Cleared Traditional

K072163 - HAPPYNEB II

K072163 is an FDA 510(k) clearance for HAPPYNEB II, manufactured by 3A Health Care S.R.L.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K072163 · 3A Health Care S.R.L. · Anesthesiology device
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Mar 2008
Decision
213d
Days
Class 2
Risk

K072163 is an FDA 510(k) clearance for the HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by 3A Health Care S.R.L. (North Reading, US). The FDA issued a Cleared decision on March 6, 2008 after a review of 213 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 3A Health Care S.R.L. devices

FDA 510(k) Submission Details - K072163

510(k) Number K072163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2007
Decision Date March 06, 2008
Days to Decision 213 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
73d slower than avg
Panel avg: 140d · This submission: 213d
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 K072163.
VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.
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K080230 · Teleflexmedical, Inc. · Jun 2008
AMSURE NEBULIZER
K070411 · Amsino International, Inc. · Oct 2007
AIRLIFE NEBULIZER CAP
K072119 · Cardinalhealth · Aug 2007
APEX MEDICAL MOBINEB, 9R-027 SERIES
K070990 · Apex Medical Corp. · May 2007