Cleared Traditional

K061394 - SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)

K061394 is an FDA 510(k) clearance for SPECIALTY NEEDLES (SPINAL NEEDLE, manufactured by Busse Hospital Disposables, Inc.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K061394 · Busse Hospital Disposables, Inc. · Anesthesiology device
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Sep 2006
Decision
110d
Days
Class 2
Risk

K061394 is an FDA 510(k) clearance for the SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE). Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Busse Hospital Disposables, Inc. (Hauppauge, US). The FDA issued a Cleared decision on September 6, 2006 after a review of 110 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 Busse Hospital Disposables, Inc. devices

FDA 510(k) Submission Details - K061394

510(k) Number K061394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2006
Decision Date September 06, 2006
Days to Decision 110 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
30d faster than avg
Panel avg: 140d · This submission: 110d
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 109
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K061394.
IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT)
K070354 · International Medical Development, Inc. · Oct 2007
ECHOSTIM FACET TIP
K063380 · Havel'S, Inc. · Apr 2007
DISCYPHOR CATHETER SYSTEM, MODEL D01A
K063071 · Kyphon, Inc. · Apr 2007
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A
K061210 · Kyphon, Inc. · Jun 2006
RX EPIDURAL NEEDLE
K053318 · Epimed International, Inc. · Feb 2006
PROBLOC, HN SERIES AND PROLONG, PL SERIES
K050499 · Life-Tech, Inc. · May 2005