Cleared Traditional

K760343 - TRAY

K760343 is the FDA 510(k) clearance for TRAY by Kendall Research Center. It is a Class 2 Anesthesiology device (product code CAZ) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K760343 · Kendall Research Center · Anesthesiology device
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Aug 1976
Decision
12d
Days
Class 2
Risk

K760343 is an FDA 510(k) clearance for the TRAY, CURITY CONTINUOUS EPIDURAL. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Kendall Research Center (Mchenry, US). The FDA issued a Cleared decision on August 11, 1976 after a review of 12 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 Kendall Research Center devices

Submission Details

510(k) Number K760343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1976
Decision Date August 11, 1976
Days to Decision 12 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d faster than avg
Panel avg: 140d · This submission: 12d
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 52
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K760343.
ANESTHESIA KIT, EPIDURAL BLOCK, CONTINU.
K770461 · Arrow Intl., Inc. · Mar 1977
ANESTHESIA KIT, EPIDURAL, SINGLE SHOT
K770356 · Arrow Intl., Inc. · Mar 1977
BRACHIAL PLEXUS BLOCK ANESTHESIA KIT
K761162 · Arrow Intl., Inc. · Dec 1976
TRAY, STERILE DISPOSABLE ARTHROGRAM
K760249 · Travenol Laboratories, S.A. · Aug 1976