Cleared Traditional

K022029 - QUINCKE SPINAL NEEDLE

K022029 is an FDA 510(k) clearance for QUINCKE SPINAL NEEDLE, manufactured by Epimed International, Inc.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K022029 · Epimed International, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
39d
Days
Class 2
Risk

K022029 is an FDA 510(k) clearance for the QUINCKE SPINAL NEEDLE. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Epimed International, Inc. (Johnstown, US). The FDA issued a Cleared decision on July 30, 2002 after a review of 39 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Epimed International, Inc. devices

FDA 510(k) Submission Details - K022029

510(k) Number K022029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2002
Decision Date July 30, 2002
Days to Decision 39 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
101d faster than avg
Panel avg: 140d · This submission: 39d
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 105
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K022029.
PENCIL POINT NEEDLE
K041843 · Epimed International, Inc. · Aug 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
PERIFIX SAFETY EPIDURAL NEEDLES
K013610 · B.Braun Medical, Inc. · Jan 2002
BALLPEN SPINAL NEEDLE W/WO INTRODUCER
K011122 · Rusch Intl. · Nov 2001