Cleared Traditional

K860833 - EPIDURAL ANESTHESIA TRAY

K860833 is the FDA 510(k) clearance for EPIDURAL ANESTHESIA TRAY by Travenol Laboratories, S.A.. It is a Class 2 Anesthesiology device (product code CAZ) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K860833 · Travenol Laboratories, S.A. · Anesthesiology device
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Apr 1986
Decision
43d
Days
Class 2
Risk

K860833 is an FDA 510(k) clearance for the EPIDURAL ANESTHESIA TRAY. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on April 17, 1986 after a review of 43 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K860833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1986
Decision Date April 17, 1986
Days to Decision 43 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
97d faster than avg
Panel avg: 140d · This submission: 43d
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 77
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K860833.
BRACHIAL PLEXUS CATHETER - BP-01200
K874105 · Arrow Intl., Inc. · Nov 1987
CONTINUOUS EPIDURAL ANESTH. KITS W/NYLON CATHETERS
K873943 · Arrow Intl., Inc. · Oct 1987
CURITY CONTINUOUS EPIDURAL ANESTHESIA TRAY
K871066 · The Kendal Co. · May 1987
REGIONAL ANESTHESIA TRAYS
K851134 · Concord Laboratories, Inc. · Jul 1985
VYGON BALLOON FOR IDENTIFICATION OF EPIDURAL 193
K851479 · Vygon Corp. · Jun 1985
EPIDURAL TRAYS
K842095 · Concord Laboratories, Inc. · Jul 1984