Cleared Traditional

K993161 - COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM

K993161 is an FDA 510(k) clearance for COPAN EASY-SWAB COLLECTION AND TRANSPOR..., manufactured by Copan Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code JTW cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K993161 · Copan Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
48d
Days
Class 1
Risk

K993161 is an FDA 510(k) clearance for the COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM. Classified as System, Transport, Aerobic (product code JTW), Class I - General Controls.

Submitted by Copan Diagnostics, Inc. (North Attleboro, US). The FDA issued a Cleared decision on November 9, 1999 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - the FDA microbiology 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 Copan Diagnostics, Inc. devices

FDA 510(k) Submission Details - K993161

510(k) Number K993161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1999
Decision Date November 09, 1999
Days to Decision 48 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 102d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

JTW Device Classification - Class 1, General Controls

Product Code JTW System, Transport, Aerobic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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 - JTW System, Transport, Aerobic

All 27
Devices cleared under the same product code (JTW) and FDA review panel - the closest regulatory comparables to K993161.
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MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE
K882580 · Precision Dynamics Corp. · Jul 1988
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K843341 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1984