Cleared Traditional

K854518 - EPIDURAL ANESTHESIA TRAY

K854518 is an FDA 510(k) clearance for EPIDURAL ANESTHESIA TRAY, manufactured by Omnis Surgical, Inc.. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K854518 · Omnis Surgical, Inc. · Anesthesiology device
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Dec 1985
Decision
41d
Days
Class 2
Risk

K854518 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 Omnis Surgical, Inc. (Deerfield, US). The FDA issued a Cleared decision on December 23, 1985 after a review of 41 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 Omnis Surgical, Inc. devices

FDA 510(k) Submission Details - K854518

510(k) Number K854518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1985
Decision Date December 23, 1985
Days to Decision 41 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 140d · This submission: 41d
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 122
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K854518.
CONTINUOUS EPIDURAL ANESTH. KITS W/NYLON CATHETERS
K873943 · Arrow Intl., Inc. · Oct 1987
CURITY CONTINUOUS EPIDURAL ANESTHESIA TRAY
K871066 · The Kendal Co. · May 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
VAS-CATH CONTINOUS EPIDURAL ANESTH. CATH/KIT/TRAY
K844982 · Vas-Cath of Canada , Ltd. · Jan 1985