Cleared Traditional

K981329 - FETH-R-KATH

K981329 is the FDA 510(k) clearance for FETH-R-KATH by Epimed International, Inc.. It is a Class 2 Anesthesiology device (product code BSO) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K981329 · Epimed International, Inc. · Anesthesiology device
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Aug 1998
Decision
135d
Days
Class 2
Risk

K981329 is an FDA 510(k) clearance for the FETH-R-KATH. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Epimed International, Inc. (Gloversville, US). The FDA issued a Cleared decision on August 26, 1998 after a review of 135 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 K981329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1998
Decision Date August 26, 1998
Days to Decision 135 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
5d faster than avg
Panel avg: 140d · This submission: 135d
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 K981329.
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SPIROL EPIDURAL CATHETER
K000886 · Abbott Laboratories · Oct 2000
CATHETER SECUREMENT DEVICE
K951092 · Baxter Healthcare Corp · Mar 1995
MEDCOMP(R) CONTINUOUS ANESTHESIA TRAY
K930539 · Medical Components, Inc. · Aug 1993
KENDALL CURITY 20 GAUGE CONTINUOUS EPIDUAL ANESTHE
K930219 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1993