Cleared Traditional

K871066 - CURITY CONTINUOUS EPIDURAL ANESTHESIA TRAY

K871066 is an FDA 510(k) clearance for CURITY CONTINUOUS EPIDURAL ANESTHESIA TRAY, manufactured by The Kendal Co.. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K871066 · The Kendal Co. · Anesthesiology device
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May 1987
Decision
59d
Days
Class 2
Risk

K871066 is an FDA 510(k) clearance for the CURITY CONTINUOUS EPIDURAL ANESTHESIA TRAY. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by The Kendal Co. (Boston, US). The FDA issued a Cleared decision on May 15, 1987 after a review of 59 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 The Kendal Co. devices

FDA 510(k) Submission Details - K871066

510(k) Number K871066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1987
Decision Date May 15, 1987
Days to Decision 59 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
81d faster than avg
Panel avg: 140d · This submission: 59d
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 83
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K871066.
AXILLARY BLOCK NEEDLE
K880970 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1988
BRACHIAL PLEXUS CATHETER - BP-01200
K874105 · Arrow Intl., Inc. · Nov 1987
CONTINUOUS EPIDURAL ANESTH. KITS W/NYLON CATHETERS
K873943 · Arrow Intl., Inc. · Oct 1987
EPIDURAL ANESTHESIA TRAY
K860833 · Travenol Laboratories, S.A. · Apr 1986
REGIONAL ANESTHESIA TRAYS
K851134 · Concord Laboratories, Inc. · Jul 1985
VYGON BALLOON FOR IDENTIFICATION OF EPIDURAL 193
K851479 · Vygon Corp. · Jun 1985