Cleared Special

K081864 - PROLONG

K081864 is an FDA 510(k) clearance for PROLONG, manufactured by Life-Tech, Inc.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Special 510(k) pathway after a 86-day FDA review.

K081864 · Life-Tech, Inc. · Anesthesiology device
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Sep 2008
Decision
86d
Days
Class 2
Risk

K081864 is an FDA 510(k) clearance for the PROLONG. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Life-Tech, Inc. (Stafford, US). The FDA issued a Cleared decision on September 25, 2008 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5150 - 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.

View all Life-Tech, Inc. devices

FDA 510(k) Submission Details - K081864

510(k) Number K081864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2008
Decision Date September 25, 2008
Days to Decision 86 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
54d faster than avg
Panel avg: 140d · This submission: 86d
Pathway characteristics
Modification to existing cleared device.

BSP Device Classification - Class 2, Special Controls

Product Code BSP Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5150
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.

Regulatory Peers - BSP Needle, Conduction, Anesthetic (w/wo Introducer)

All 69
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