Cleared Traditional

K822691 - VYGON EPIDURAL ANAESTHESIA TRAY

K822691 is an FDA 510(k) clearance for VYGON EPIDURAL ANAESTHESIA TRAY, manufactured by Exco, Inc.. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K822691 · Exco, Inc. · Anesthesiology device
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Oct 1982
Decision
42d
Days
Class 2
Risk

K822691 is an FDA 510(k) clearance for the VYGON EPIDURAL ANAESTHESIA TRAY. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Exco, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 15, 1982 after a review of 42 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 Exco, Inc. devices

FDA 510(k) Submission Details - K822691

510(k) Number K822691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1982
Decision Date October 15, 1982
Days to Decision 42 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
98d faster than avg
Panel avg: 140d · This submission: 42d
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 K822691.
CONTINUOUS EPIDURAL ANESTHES. TRAY
K840179 · Burron Medical Products, Inc. · Feb 1984
BRACHIAL PLEXUS ANESTHESIA TRAY
K840287 · Burron Medical Products, Inc. · Feb 1984
EPIDURAL SYRINGE
K832778 · Concord Laboratories, Inc. · Sep 1983
PERFIX SET FOR EPIDURAL ANESTHESIA W/TUO
K813186 · Burron Medical Products, Inc. · Dec 1981
REGIONAL INTRAVENOUS ANESTHESIA KIT
K802290 · Stanco Medical, Inc. · Oct 1980
ARROW POSITIVE PLACEMENT CON/EPIDURAL AN
K801912 · Arrow Intl., Inc. · Sep 1980