Cleared Special

K081864 - PROLONG (FDA 510(k) Clearance)

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

K081864 · Life-Tech, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
53d faster than avg
Panel avg: 139d · This submission: 86d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 151
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K081864.
SonoMSK
K243690 · PAJUNK GmbH Medizintechnologie · Jul 2025
SonoPlex STIM
K243682 · PAJUNK GmbH Medizintechnologie · Jun 2025
SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture
K250774 · PAJUNK GmbH Medizintechnologie · Jun 2025
SonoTAP and SonoTAP II
K243525 · PAJUNK GmbH Medizintechnologie · Mar 2025
SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology
K241953 · PAJUNK GmbH Medizintechnologie · Nov 2024
SonoBlock
K241954 · PAJUNK GmbH Medizintechnologie · Sep 2024