Cleared Traditional

PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES (K040965) - FDA 510(k) Clearance

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

K040965 · Pajunk GmbH · Anesthesiology device
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Sep 2004
Decision
146d
Days
Class 2
Risk

K040965 is an FDA 510(k) clearance for the PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Pajunk GmbH (Flemington, US). The FDA issued a Cleared decision on September 7, 2004 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5150 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pajunk GmbH devices

Submission Details

510(k) Number K040965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2004
Decision Date September 07, 2004
Days to Decision 146 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
6d slower than avg
Panel avg: 140d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K040965.
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