Cleared Traditional

K802290 - REGIONAL INTRAVENOUS ANESTHESIA KIT

K802290 is an FDA 510(k) clearance for REGIONAL INTRAVENOUS ANESTHESIA KIT, manufactured by Stanco Medical, Inc.. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K802290 · Stanco Medical, Inc. · Anesthesiology device
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Oct 1980
Decision
28d
Days
Class 2
Risk

K802290 is an FDA 510(k) clearance for the REGIONAL INTRAVENOUS ANESTHESIA KIT. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Stanco Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1980 after a review of 28 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 Stanco Medical, Inc. devices

FDA 510(k) Submission Details - K802290

510(k) Number K802290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1980
Decision Date October 17, 1980
Days to Decision 28 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
112d faster than avg
Panel avg: 140d · This submission: 28d
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 K802290.
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
ARROW POSITIVE PLACEMENT CON/EPIDURAL AN
K801912 · Arrow Intl., Inc. · Sep 1980
CURITY PARACERVICAL/PUDENDAL BLOCK ANES
K801724 · The Kendal Co. · Aug 1980
POSITIVE PLACEMENT ANETHESIA KIT
K781469 · Arrow Intl., Inc. · Jan 1979