Cleared Special

K012584 - MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K012584 · Bd · Anesthesiology device
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Sep 2001
Decision
27d
Days
Class 2
Risk

K012584 is an FDA 510(k) clearance for the MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Bd (Franklin Lakes, US). The FDA issued a Cleared decision on September 6, 2001 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K012584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2001
Decision Date September 06, 2001
Days to Decision 27 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 139d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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.