Cleared Traditional

FINN CHAMBERS AQUA (K123184) - FDA 510(k) Clearance

Class I General Hospital device.

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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Submission Details

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.

Device Classification

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.