Cleared Traditional

K954584 - RACZ EPIDURAL CATHETER

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

K954584 · Medic Evaluation Devices & Instruments Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K954584

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
Combination Product No
PCCP Authorized No
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.

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 K954584.
FETH-R-KATH
K981329 · Epimed International, Inc. · Aug 1998
INTERPLEURAL ANESTHESIA CATHETER
K971851 · Axiom Medical, Inc. · Jan 1998
COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER)
K951927 · Csen , Ltd. · May 1997
CATHETER SECUREMENT DEVICE
K951092 · Baxter Healthcare Corp · Mar 1995
CONCORD/PORTEX EPIDURAL CATHETERS
K935927 · Smiths Industries Medical Systems, Inc. · Sep 1994
MEDCOMP(R) CONTINUOUS ANESTHESIA TRAY
K930539 · Medical Components, Inc. · Aug 1993