Cleared Traditional

K770461 - ANESTHESIA KIT

K770461 is an FDA 510(k) clearance for 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 7-day FDA review.

K770461 · Arrow Intl., Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1977
Decision
7d
Days
Class 2
Risk

K770461 is an FDA 510(k) clearance for the ANESTHESIA KIT, EPIDURAL BLOCK, CONTINU.. 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 March 16, 1977 after a review of 7 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 - K770461

510(k) Number K770461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1977
Decision Date March 16, 1977
Days to Decision 7 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
133d faster than avg
Panel avg: 140d · This submission: 7d
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 K770461.
CURITY PARACERVICAL/PUDENDAL BLOCK ANES
K801724 · The Kendal Co. · Aug 1980
POSITIVE PLACEMENT ANETHESIA KIT
K781469 · Arrow Intl., Inc. · Jan 1979
TRAY, ANESTHESIA, EPIDURAL, CONTINUOUS
K770571 · Travenol Laboratories, S.A. · Mar 1977
ANESTHESIA KIT, EPIDURAL, SINGLE SHOT
K770356 · Arrow Intl., Inc. · Mar 1977
BRACHIAL PLEXUS BLOCK ANESTHESIA KIT
K761162 · Arrow Intl., Inc. · Dec 1976
CIRCUIT, INTENSIVE CARE VENTILATOR
K760352 · Monaghan Medical Corp. · Aug 1976