Cleared Traditional

K072005 - RK EPIDURAL NEEDLE

K072005 is an FDA 510(k) clearance for RK EPIDURAL NEEDLE, manufactured by Epimed International. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K072005 · Epimed International · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
199d
Days
Class 2
Risk

K072005 is an FDA 510(k) clearance for the RK EPIDURAL NEEDLE. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Epimed International (Johnston, US). The FDA issued a Cleared decision on February 7, 2008 after a review of 199 days - an extended review 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: 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 Epimed International devices

FDA 510(k) Submission Details - K072005

510(k) Number K072005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2007
Decision Date February 07, 2008
Days to Decision 199 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 140d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 73
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K072005.
PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G
K090261 · Smiths Medical Asd, Inc. · May 2009
BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237
K081446 · Becton, Dickinson & CO · Jul 2008
MODIFICATION TO:SPECIALTY NEEDLES
K073222 · Busse Hospital Disposables, Inc. · Apr 2008
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
WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
K030618 · Wilson-Cook Medical, Inc. · May 2003