Cleared Traditional

K951927 - COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER)

K951927 is an FDA 510(k) clearance for COMBINED END-MULTIPLE LATERAL HOLES EPI..., manufactured by Csen , Ltd.. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Traditional 510(k) pathway after a 767-day FDA review.

K951927 · Csen , Ltd. · Anesthesiology device
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May 1997
Decision
767d
Days
Class 2
Risk

K951927 is an FDA 510(k) clearance for the COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER). Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Csen , Ltd. (Israel, IL). The FDA issued a Cleared decision on May 30, 1997 after a review of 767 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Csen , Ltd. devices

FDA 510(k) Submission Details - K951927

510(k) Number K951927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1995
Decision Date May 30, 1997
Days to Decision 767 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
627d slower than avg
Panel avg: 140d · This submission: 767d
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 54
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K951927.
SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17
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CATHETER SECUREMENT DEVICE
K951092 · Baxter Healthcare Corp · Mar 1995
CONCORD/PORTEX EPIDURAL CATHETERS
K935927 · Smiths Industries Medical Systems, Inc. · Sep 1994