Cleared Traditional

K935927 - CONCORD/PORTEX EPIDURAL CATHETERS

K935927 is an FDA 510(k) clearance for CONCORD/PORTEX EPIDURAL CATHETERS, manufactured by Smiths Industries Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K935927 · Smiths Industries Medical Systems, Inc. · Anesthesiology device
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Sep 1994
Decision
270d
Days
Class 2
Risk

K935927 is an FDA 510(k) clearance for the CONCORD/PORTEX EPIDURAL CATHETERS. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Smiths Industries Medical Systems, Inc. (Keene, US). The FDA issued a Cleared decision on September 9, 1994 after a review of 270 days - an extended review cycle.

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 Smiths Industries Medical Systems, Inc. devices

FDA 510(k) Submission Details - K935927

510(k) Number K935927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1993
Decision Date September 09, 1994
Days to Decision 270 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 140d · This submission: 270d
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 44
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K935927.
AXIOM MULTIPURPOSE WOUND DRAIN
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INTERPLEURAL ANESTHESIA CATHETER
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CATHETER SECUREMENT DEVICE
K951092 · Baxter Healthcare Corp · Mar 1995
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KENDALL CURITY 20 GAUGE CONTINUOUS EPIDUAL ANESTHE
K930219 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1993
KENDALL CURITY CONTINUOUS EPIDDUAL ANESTHESIA CATH
K922113 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1992