Cleared Traditional

K954584 - RACZ EPIDURAL CATHETER

K954584 is the FDA 510(k) clearance for RACZ EPIDURAL CATHETER by Medic Evaluation Devices & Instruments Corp.. It is a Class 2 Anesthesiology device (product code BSO) cleared through the Traditional 510(k) pathway after a 372-day FDA review.

K954584 · Medic Evaluation Devices & Instruments Corp. · Anesthesiology device
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Oct 1996
Decision
372d
Days
Class 2
Risk

K954584 is an FDA 510(k) clearance for the RACZ EPIDURAL CATHETER. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Medic Evaluation Devices & Instruments Corp. (Gloversville, US). The FDA issued a Cleared decision on October 8, 1996 after a review of 372 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Medic Evaluation Devices & Instruments Corp. devices

Submission Details

510(k) Number K954584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1995
Decision Date October 08, 1996
Days to Decision 372 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
232d slower than avg
Panel avg: 140d · This submission: 372d
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 K954584.
EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
K023233 · Ebi, L.P. · Dec 2002
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