Cleared Traditional

K023140 - VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124

K023140 is an FDA 510(k) clearance for VERSA-KATH EPIDURAL CATHETER, manufactured by Epimed International, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K023140

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.

BSO Device Classification - Class 2, Special Controls

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 62
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K023140.
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