Cleared Traditional

K983125 - EPIDURAL CATHETER MODELS 1210/1200

K983125 is an FDA 510(k) clearance for EPIDURAL CATHETER MODELS 1210/1200, manufactured by Rusch Intl.. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K983125 · Rusch Intl. · Anesthesiology device
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Nov 1998
Decision
70d
Days
Class 2
Risk

K983125 is an FDA 510(k) clearance for the EPIDURAL CATHETER MODELS 1210/1200. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Rusch Intl. (Jeffrey, US). The FDA issued a Cleared decision on November 17, 1998 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5140 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rusch Intl. devices

FDA 510(k) Submission Details - K983125

510(k) Number K983125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1998
Decision Date November 17, 1998
Days to Decision 70 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 140d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAZ Device Classification - Class 2, Special Controls

Product Code CAZ Anesthesia Conduction Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5140
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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 - CAZ Anesthesia Conduction Kit

All 114
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K983125.
19 GA PLASTIC REINFORCED EPIDURAL CATHETER
K001587 · Arrow Intl., Inc. · Jul 2000
PROLONG, MODELS PL50, PL100, PL150
K001129 · Life-Tech Intl., Inc. · Jul 2000
EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS
K991719 · Medimex Holfeld GmbH & Co. · Aug 1999
SOFT TIP EPIDURAL CATHETER KIT
K971233 · B.Braun Medical, Inc. · Oct 1997
PERIFIX PEDIATRIC EPIDURAL KIT
K962696 · B.Braun Medical, Inc. · Apr 1997
REGIONAL ANESTHESIA TRAYS
K965017 · Smiths Industries Medical Systems, Inc. · Mar 1997