Cleared Traditional

K965017 - REGIONAL ANESTHESIA TRAYS

K965017 is an FDA 510(k) clearance for REGIONAL ANESTHESIA TRAYS, manufactured by Smiths Industries Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K965017 · Smiths Industries Medical Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
88d
Days
Class 2
Risk

K965017 is an FDA 510(k) clearance for the REGIONAL ANESTHESIA TRAYS. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Smiths Industries Medical Systems, Inc. (Keene, US). The FDA issued a Cleared decision on March 14, 1997 after a review of 88 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 Smiths Industries Medical Systems, Inc. devices

FDA 510(k) Submission Details - K965017

510(k) Number K965017 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received December 16, 1996
Decision Date March 14, 1997
Days to Decision 88 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
52d faster than avg
Panel avg: 140d · This submission: 88d
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 97
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K965017.
EPIDURAL CATHETER MODELS 1210/1200
K983125 · Rusch Intl. · Nov 1998
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
KENDALL BLUNT TUOHY EPIDURAL NEEDLE
K954706 · Kendall Healthcare Products Co. Div.Of Tyco Health · May 1996
B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY
K954953 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1996