Cleared Traditional

K070354 - IMD'S ANESTHESIA NEEDLES (TUOHY

K070354 is an FDA 510(k) clearance for IMD'S ANESTHESIA NEEDLES (TUOHY, manufactured by International Medical Development, Inc.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K070354 · International Medical Development, Inc. · Anesthesiology device
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Oct 2007
Decision
241d
Days
Class 2
Risk

K070354 is an FDA 510(k) clearance for the IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT). Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by International Medical Development, Inc. (Huntsville, US). The FDA issued a Cleared decision on October 5, 2007 after a review of 241 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 International Medical Development, Inc. devices

FDA 510(k) Submission Details - K070354

510(k) Number K070354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2007
Decision Date October 05, 2007
Days to Decision 241 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 slower than avg
Panel avg: 140d · This submission: 241d
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 85
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K070354.
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
MODIFICATION TO: PLEXALONG SETS
K042979 · Pajunk GmbH · Dec 2004
PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES
K040965 · Pajunk GmbH · Sep 2004