Cleared Traditional

K964783 - EPIDURAL MINI KIT

K964783 is the FDA 510(k) clearance for EPIDURAL MINI KIT by Alexander Medical, Inc.. It is a Class 2 Anesthesiology device (product code CAZ) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K964783 · Alexander Medical, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Feb 1997
Decision
77d
Days
Class 2
Risk

K964783 is an FDA 510(k) clearance for the EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Alexander Medical, Inc. (Rockville, US). The FDA issued a Cleared decision on February 12, 1997 after a review of 77 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 Alexander Medical, Inc. devices

Submission Details

510(k) Number K964783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1996
Decision Date February 12, 1997
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 140d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 37
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K964783.
19 GA PLASTIC REINFORCED EPIDURAL CATHETER
K001587 · Arrow Intl., Inc. · Jul 2000
SOFT TIP EPIDURAL CATHETER KIT
K971233 · B.Braun Medical, Inc. · Oct 1997
PERIFIX PEDIATRIC EPIDURAL KIT
K962696 · B.Braun Medical, Inc. · Apr 1997
SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM
K962880 · Sherwood Medical Co. · Dec 1996
B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY
K954953 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1996
BD PERISAFE EPIDURAL ANESTHESIA TRAY
K953790 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1995