Cleared Special

MODIFICATION TO: PLEXALONG SETS (K042979) - FDA 510(k) Clearance

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

K042979 · Pajunk GmbH · Anesthesiology device
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Dec 2004
Decision
53d
Days
Class 2
Risk

K042979 is an FDA 510(k) clearance for the MODIFICATION TO: PLEXALONG SETS. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Pajunk GmbH (Corvallis, US). The FDA issued a Cleared decision on December 21, 2004 after a review of 53 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 Pajunk GmbH devices

Submission Details

510(k) Number K042979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2004
Decision Date December 21, 2004
Days to Decision 53 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 140d · This submission: 53d
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 44
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K042979.
CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680
K100241 · B.Braun Medical, Inc. · Apr 2010
FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE
K093209 · Cook, Inc. · Feb 2010
BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237
K081446 · Becton, Dickinson & CO · Jul 2008
WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
K030618 · Wilson-Cook Medical, Inc. · May 2003
PERIFIX SAFETY EPIDURAL NEEDLES
K013610 · B.Braun Medical, Inc. · Jan 2002
CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA.
K951949 · Baxter Healthcare Corp · Aug 1995