Cleared Traditional

K071269 - HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM (FDA 510(k) Clearance)

Class I Anesthesiology device.

K071269 · Smiths Medical Asd, Inc. · Anesthesiology device
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Aug 2007
Decision
86d
Days
Class 1
Risk

K071269 is an FDA 510(k) clearance for the HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM. Classified as Arterial Blood Sampling Kit (product code CBT), Class I - General Controls.

Submitted by Smiths Medical Asd, Inc. (Dublin, US). The FDA issued a Cleared decision on August 1, 2007 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1100 - 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 Smiths Medical Asd, Inc. devices

Submission Details

510(k) Number K071269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2007
Decision Date August 01, 2007
Days to Decision 86 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
53d faster than avg
Panel avg: 139d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CBT Arterial Blood Sampling Kit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.1100
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 I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.