Cleared Traditional

FINN CHAMBER (R) (K013820) - FDA 510(k) Clearance

Class I General Hospital device.

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

Submission Details

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.

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.