Cleared Traditional

K110053 - CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT (FDA 510(k) Clearance)

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

K110053 · Smiths Medical Asd, Inc. · Anesthesiology device
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Sep 2012
Decision
616d
Days
Class 2
Risk

K110053 is an FDA 510(k) clearance for the CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SY.... Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Smiths Medical Asd, Inc. (Keene, US). The FDA issued a Cleared decision on September 14, 2012 after a review of 616 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Smiths Medical Asd, Inc. devices

Submission Details

510(k) Number K110053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2011
Decision Date September 14, 2012
Days to Decision 616 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
477d slower than avg
Panel avg: 139d · This submission: 616d
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.