Cleared Traditional

K840287 - BRACHIAL PLEXUS ANESTHESIA TRAY

K840287 is an FDA 510(k) clearance for BRACHIAL PLEXUS ANESTHESIA TRAY, manufactured by Burron Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K840287 · Burron Medical Products, Inc. · Anesthesiology device
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Feb 1984
Decision
30d
Days
Class 2
Risk

K840287 is an FDA 510(k) clearance for the BRACHIAL PLEXUS ANESTHESIA TRAY. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Burron Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on February 23, 1984 after a review of 30 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 Burron Medical Products, Inc. devices

FDA 510(k) Submission Details - K840287

510(k) Number K840287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1984
Decision Date February 23, 1984
Days to Decision 30 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
110d faster than avg
Panel avg: 140d · This submission: 30d
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 100
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K840287.
VAS-CATH CONTINOUS EPIDURAL ANESTH. CATH/KIT/TRAY
K844982 · Vas-Cath of Canada , Ltd. · Jan 1985
EPIDURAL TRAYS
K842095 · Concord Laboratories, Inc. · Jul 1984
CONTINUOUS EPIDURAL ANESTHES. TRAY
K840179 · Burron Medical Products, Inc. · Feb 1984
EPIDURAL SYRINGE
K832778 · Concord Laboratories, Inc. · Sep 1983
VYGON EPIDURAL ANAESTHESIA TRAY
K822691 · Exco, Inc. · Oct 1982
PERFIX SET FOR EPIDURAL ANESTHESIA W/TUO
K813186 · Burron Medical Products, Inc. · Dec 1981