Cleared Traditional

CONCORD/PORTEX EPIDURAL CATHETERS (K935927) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 23
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K935927.
PERIFIX CATHETER CONNECTOR
K022019 · B.Braun Medical, Inc. · Aug 2002
SPIROL EPIDURAL CATHETER
K000886 · Abbott Laboratories · Oct 2000
CATHETER SECUREMENT DEVICE
K951092 · Baxter Healthcare Corp · Mar 1995
PHARMASEAL EPIDURAL CATHETER
K896712 · Baxter Healthcare Corp · Jun 1990
PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL
K897194 · Baxter Healthcare Corp · Jun 1990
EPI-CATH(TM) EPIDURAL CATHETER
K895204 · Abbott Laboratories · Nov 1989