Cleared Traditional

K013820 - FINN CHAMBER (R)

K013820 is an FDA 510(k) clearance for FINN CHAMBER, manufactured by Epitest Ltd. OY. The device is a Class 1 General Hospital device with product code KXF cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K013820 · Epitest Ltd. OY · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
75d
Days
Class 1
Risk

K013820 is an FDA 510(k) clearance for the FINN CHAMBER (R). Classified as Applicator, Absorbent Tipped, Non-sterile (product code KXF), Class I - General Controls.

Submitted by Epitest Ltd. OY (Petaluma, US). The FDA issued a Cleared decision on January 30, 2002 after a review of 75 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.

View all Epitest Ltd. OY devices

FDA 510(k) Submission Details - K013820

510(k) Number K013820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2001
Decision Date January 30, 2002
Days to Decision 75 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 129d · This submission: 75d
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 13
Devices cleared under the same product code (KXF) and FDA review panel - the closest regulatory comparables to K013820.
FINN CHAMBERS AQUA
K123184 · Smartpractice · Dec 2012
ALLERGEAZE R CLEAR
K103409 · Smartpractice · Mar 2011
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
SUBCLAVIAN CATHETER INSERTION TRAY
K802580 · American Pharmaseal Div. Ahsc · Nov 1980