Cleared Traditional

K951927 - COMBINED END-MULTIPLE LATERAL HOLES EPI...

K951927 is the FDA 510(k) clearance for COMBINED END-MULTIPLE LATERAL HOLES EPI... by Csen , Ltd.. It is a Class 2 Anesthesiology device (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

Submission Details

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
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.

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 24
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K951927.
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SPIROL EPIDURAL CATHETER
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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