Cleared Traditional

K031128 - B-SMART, MODEL B-01 (FDA 510(k) Clearance)

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

K031128 · Macosta Medical USA, LLC · Anesthesiology device
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Jan 2004
Decision
281d
Days
Class 2
Risk

K031128 is an FDA 510(k) clearance for the B-SMART, MODEL B-01. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Macosta Medical USA, LLC (Ayer, US). The FDA issued a Cleared decision on January 15, 2004 after a review of 281 days - an extended review 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: 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.

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Submission Details

510(k) Number K031128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2003
Decision Date January 15, 2004
Days to Decision 281 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 139d · This submission: 281d
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.