Cleared Traditional

K951949 - CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA.

K951949 is an FDA 510(k) clearance for CLEAR HUB SPINAL NEEDLE, manufactured by Baxter Healthcare Corp. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K951949 · Baxter Healthcare Corp · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K951949

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
33d faster than avg
Panel avg: 140d · This submission: 107d
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 151
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K951949.
POLYMEDIC SPINAL NEEDLE AND INTRODUCER
K940061 · Techniques Medicales DE Navaree · Dec 1995
GLOBAL MEDICAL PRODUCTS TUOHY & CRAWFORD EPIDURAL NEEDLE W/PLASTIC HUB
K952275 · Global Medical Prods, Inc. · Oct 1995
EPIDURAL NEEDLE
K942863 · Spinal Specialties, Inc. · Aug 1995
ATRAUMATIC PENCIL POINT SPINAL NEEDLE
K945965 · Avid N.I.T., Inc. · Aug 1995
HOLGRATH METAL-HUB, EPIDURAL NEEDLE
K946047 · Holgrath Medical Technologies, Inc. · Jul 1995
SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE
K950820 · Spinal Specialties, Inc. · Jun 1995
K951949 · CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA.
Download PDF FDA Summary Baxter Healthcare Corp