Cleared Special

K102007 - PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, (FDA 510(k) Clearance)

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

K102007 · Life-Tech, Inc. · Anesthesiology device
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Dec 2010
Decision
159d
Days
Class 2
Risk

K102007 is an FDA 510(k) clearance for the PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Life-Tech, Inc. (Stafford, US). The FDA issued a Cleared decision on December 22, 2010 after a review of 159 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Life-Tech, Inc. devices

Submission Details

510(k) Number K102007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2010
Decision Date December 22, 2010
Days to Decision 159 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 139d · This submission: 159d
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.