Cleared Traditional

K063160 - ALLERGEAZE PATCH TEST CHAMBERS

K063160 is an FDA 510(k) clearance for ALLERGEAZE PATCH TEST CHAMBERS, manufactured by Smartpractice. The device is a Class 1 General Hospital device with product code KXF cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K063160 · Smartpractice · General Hospital
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Dec 2006
Decision
66d
Days
Class 1
Risk

K063160 is an FDA 510(k) clearance for the ALLERGEAZE PATCH TEST CHAMBERS. Classified as Applicator, Absorbent Tipped, Non-sterile (product code KXF), Class I - General Controls.

Submitted by Smartpractice (Phoenix, US). The FDA issued a Cleared decision on December 22, 2006 after a review of 66 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6025 - the FDA general hospital 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K063160

510(k) Number K063160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2006
Decision Date December 22, 2006
Days to Decision 66 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 129d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

KXF Device Classification - Class 1, General Controls

Product Code KXF Applicator, Absorbent Tipped, Non-sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6025
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KXF Applicator, Absorbent Tipped, Non-sterile

All 17
Devices cleared under the same product code (KXF) and FDA review panel - the closest regulatory comparables to K063160.
FINN CHAMBERS AQUA
K123184 · Smartpractice · Dec 2012
ALLERGEAZE R CLEAR
K103409 · Smartpractice · Mar 2011
FINN CHAMBER (R)
K013820 · Epitest Ltd. OY · Jan 2002
IQ CHAMBERS
K992553 · Dormer Laboratories, Inc. · Apr 2000
EAR APPLICATOR, CATALOG NO. 2229
K870762 · Treace Medical, Inc. · Mar 1987
COTTON TIPPED APPLICATORS, SINGLE
K843720 · Abco Dealers, Inc. · Oct 1984
K063160 · ALLERGEAZE PATCH TEST CHAMBERS
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