Cleared Traditional

CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA. (K951949) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K951949 · Baxter Healthcare Corp · Anesthesiology device
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Aug 1995
Decision
107d
Days
Class 2
Risk

K951949 is an FDA 510(k) clearance for the CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA.. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on August 11, 1995 after a review of 107 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K951949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1995
Decision Date August 11, 1995
Days to Decision 107 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
32d faster than avg
Panel avg: 139d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 35
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K951949.
FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE
K101728 · Cook, Inc. · Aug 2010
FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE
K093209 · Cook, Inc. · Feb 2010
BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237
K081446 · Becton, Dickinson & CO · Jul 2008
MONOJECT WHITACRE POINT SPINAL NEEDLE (27G X 3 1/2)
K951312 · Sherwood Medical Co. · May 1995
MONOJECT TUOHY POINT EPIDURAL NEEDLE (22G X 3 1/2)
K951411 · Sherwood Medical Co. · May 1995
MONOJECT DIAMOND POINT SPINAL NEEDLE (28G X 3 1/2)
K951265 · Sherwood Medical Co. · Apr 1995