Cleared Traditional

K023140 - VERSA-KATH EPIDURAL CATHETER

K023140 is the FDA 510(k) clearance for VERSA-KATH EPIDURAL CATHETER by Epimed International, Inc.. It is a Class 2 Anesthesiology device (product code BSO) cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K023140 · Epimed International, Inc. · Anesthesiology device
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Aug 2003
Decision
329d
Days
Class 2
Risk

K023140 is an FDA 510(k) clearance for the VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Epimed International, Inc. (Johnstown, US). The FDA issued a Cleared decision on August 15, 2003 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5120 - the FDA anesthesiology and respiratory 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Epimed International, Inc. devices

Submission Details

510(k) Number K023140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2002
Decision Date August 15, 2003
Days to Decision 329 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 140d · This submission: 329d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BSO Catheter, Conduction, Anesthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BSO Catheter, Conduction, Anesthetic

All 39
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K023140.
MODIFICATION TO SOAKER CATHETER
K043456 · I-Flow Corp. · Jan 2005
PERIFIX CATHETER AND CONTIPLEX CATHETER
K042488 · B.Braun Medical, Inc. · Sep 2004
MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
K032390 · Ebi, L.P. · Aug 2003
EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
K023233 · Ebi, L.P. · Dec 2002
PERIFIX CATHETER CONNECTOR
K022019 · B.Braun Medical, Inc. · Aug 2002
SPIROL EPIDURAL CATHETER
K000886 · Abbott Laboratories · Oct 2000