Cleared Traditional

K123184 - FINN CHAMBERS AQUA

K123184 is an FDA 510(k) clearance for FINN CHAMBERS AQUA, 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 70-day FDA review.

K123184 · Smartpractice · General Hospital
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Dec 2012
Decision
70d
Days
Class 1
Risk

K123184 is an FDA 510(k) clearance for the FINN CHAMBERS AQUA. 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 19, 2012 after a review of 70 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.

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FDA 510(k) Submission Details - K123184

510(k) Number K123184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2012
Decision Date December 19, 2012
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 129d · This submission: 70d
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 10
Devices cleared under the same product code (KXF) and FDA review panel - the closest regulatory comparables to K123184.
EAR APPLICATOR, CATALOG NO. 2229
K870762 · Treace Medical, Inc. · Mar 1987
COTTON TIPPED APPLICATORS, SINGLE
K843720 · Abco Dealers, Inc. · Oct 1984
SUBCLAVIAN CATHETER INSERTION TRAY
K802580 · American Pharmaseal Div. Ahsc · Nov 1980
EYE APPLICATORS CAT.#980-983
K802016 · Pollak (Intl.), Ltd. · Sep 1980
PREP SET CAT.#908
K802020 · Pollak (Intl.), Ltd. · Sep 1980
DEXIDE DISPOSABLE PREP STICK
K791168 · Dexide, Inc. · Jul 1979