Cleared Traditional

DURASAFE B-D COMBINED SPINAL EPIDURAL ANESTHESIA (K932249) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K932249 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Anesthesiology device
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Aug 1993
Decision
109d
Days
Class 2
Risk

K932249 is an FDA 510(k) clearance for the DURASAFE B-D COMBINED SPINAL EPIDURAL ANESTHESIA. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on August 27, 1993 after a review of 109 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K932249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 10, 1993
Decision Date August 27, 1993
Days to Decision 109 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 139d · This submission: 109d
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 25
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K932249.
B-D SPINAL ANESTHESIA TRAY SPINAL
K953467 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1995
SENSI-TOUCH EPIDURAL ANESTHESIA TRAY
K950929 · Sherwood Medical Co. · May 1995
B-D DURASAFE)TM) VARIABLE EXTENSION COMBINED SPINAL EPIDURAL *CSE) NEEDLE SET/KIT
K945497 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1995
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
MEDTRONIC EPIDURAL CATHETER KIT MODEL 8716
K882394 · Medtronic Vascular · Sep 1988