Cleared Traditional

K040965 - PAJUNK TUOHY NEEDLES

K040965 is an FDA 510(k) clearance for PAJUNK TUOHY NEEDLES, manufactured by Pajunk GmbH. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 146-day FDA review.

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

FDA 510(k) Submission Details - K040965

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
Combination Product No
PCCP Authorized No
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.

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 77
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K040965.
DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE
K063350 · PAJUNK GmbH Medizintechnologie · Feb 2008
SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)
K061394 · Busse Hospital Disposables, Inc. · Sep 2006
MODIFICATION TO: PLEXALONG SETS
K042979 · Pajunk GmbH · Dec 2004
WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
K030618 · Wilson-Cook Medical, Inc. · May 2003
MODIFICATION TO PLEXOLONG SETS
K023218 · Pajunk GmbH · Mar 2003
LUTZ NEEDLE
K013892 · Ballard Medical Products · Jul 2002