Cleared Traditional

K902312 - COSPAN PEDIATRIC CONTINUOUS SPINAL ANES...

K902312 is an FDA 510(k) clearance for COSPAN PEDIATRIC CONTINUOUS SPINAL ANES..., manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K902312 · Kendall Healthcare Products Co. Div.Of Tyco Health · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Jul 1990
Decision
68d
Days
Class 2
Risk

K902312 is an FDA 510(k) clearance for the COSPAN PEDIATRIC CONTINUOUS SPINAL ANESTHESIA TRAY. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Salt Lake City, US). The FDA issued a Cleared decision on July 30, 1990 after a review of 68 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K902312

510(k) Number K902312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1990
Decision Date July 30, 1990
Days to Decision 68 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
72d faster than avg
Panel avg: 140d · This submission: 68d
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 98
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K902312.
COSPAN CONTINUOUS SPINAL ANESTHESIA TRAY
K904101 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1990
CURITY NERVE BLOCK TRAY
K903887 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1990
CURITY PEDIATRIC CONTINUOUS CAUDAL ANESTHESIA TRAY
K902647 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1990
PARACERVICAL/PUDENDAL TRAYS
K896799 · Westmark, Sterile Packing Systems, Inc. (Sps) · Apr 1990
MEDTRONIC EPIDURAL CATHETER KIT MODEL 8717
K896392 · Medtronic Vascular · Nov 1989
HIBERNATION KIT
K892660 · Devon Industries, Inc. · Aug 1989