Cleared Traditional

K885278 - EPIDURAL ANESTHESIA TRAY

K885278 is the FDA 510(k) clearance for EPIDURAL ANESTHESIA TRAY by Preferred Medical Products. It is a Class 2 Anesthesiology device (product code CAZ) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K885278 · Preferred Medical Products · Anesthesiology device
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Mar 1989
Decision
83d
Days
Class 2
Risk

K885278 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 Preferred Medical Products (Richmond Hill L4b1h4, CA). The FDA issued a Cleared decision on March 16, 1989 after a review of 83 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 Preferred Medical Products devices

Submission Details

510(k) Number K885278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1988
Decision Date March 16, 1989
Days to Decision 83 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 140d · This submission: 83d
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 37
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K885278.
B-D LOSS OF RESISTANCE SYRINGE
K925902 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1993
MEDTRONIC EPIDURAL CATHETER KIT MODEL 8717
K896392 · Medtronic Vascular · Nov 1989
INTERPLEURAL ANESTHESIA KIT W/POLYURETHANE CATH.
K891281 · Arrow Intl., Inc. · Jul 1989
CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER
K884552 · Arrow Intl., Inc. · Mar 1989
MEDTRONIC EPIDURAL CATHETER KIT MODEL 8716
K882394 · Medtronic Vascular · Sep 1988
AXILLARY BLOCK NEEDLE
K880970 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1988