Cleared Traditional

K761162 - BRACHIAL PLEXUS BLOCK ANESTHESIA KIT

K761162 is an FDA 510(k) clearance for BRACHIAL PLEXUS BLOCK ANESTHESIA KIT, manufactured by Arrow Intl., Inc.. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K761162 · Arrow Intl., Inc. · Anesthesiology device
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Dec 1976
Decision
9d
Days
Class 2
Risk

K761162 is an FDA 510(k) clearance for the BRACHIAL PLEXUS BLOCK ANESTHESIA KIT. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 9, 1976 after a review of 9 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K761162

510(k) Number K761162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1976
Decision Date December 09, 1976
Days to Decision 9 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 140d · This submission: 9d
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 82
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K761162.
TRAY, ANESTHESIA, EPIDURAL, CONTINUOUS
K770571 · Travenol Laboratories, S.A. · Mar 1977
ANESTHESIA KIT, EPIDURAL BLOCK, CONTINU.
K770461 · Arrow Intl., Inc. · Mar 1977
ANESTHESIA KIT, EPIDURAL, SINGLE SHOT
K770356 · Arrow Intl., Inc. · Mar 1977
CIRCUIT, INTENSIVE CARE VENTILATOR
K760352 · Monaghan Medical Corp. · Aug 1976
TRAY, STERILE DISPOSABLE ARTHROGRAM
K760249 · Travenol Laboratories, S.A. · Aug 1976