Cleared Traditional

K920305 - PHARMASEAL CLEAR HUB SPINAL NEEDLE

K920305 is an FDA 510(k) clearance for PHARMASEAL 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 371-day FDA review.

K920305 · Baxter Healthcare Corp · Anesthesiology device
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Jan 1993
Decision
371d
Days
Class 2
Risk

K920305 is an FDA 510(k) clearance for the PHARMASEAL CLEAR HUB SPINAL NEEDLE. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on January 27, 1993 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K920305

510(k) Number K920305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1992
Decision Date January 27, 1993
Days to Decision 371 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
231d slower than avg
Panel avg: 140d · This submission: 371d
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 110
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K920305.
PENCIL POINT SPINAL NEEDLE AND TRAY
K932569 · B. Braun of America, Inc. · Jan 1994
ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY
K932400 · B. Braun of America, Inc. · Dec 1993
PAJUNK STANDARD SPROTTE NEEDLE W/ INTRODUCER CANN.
K923003 · Rusch, Inc. · Apr 1993
CURITY CALIBRATED TUOHY TYPE EPIDURAL NEEDLE
K921288 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jan 1993
ATRAUMATIC SPECIAL SPROTTE NEEDLE
K911221 · Pajunk GmbH · Jul 1992
ATRAUMATIC STANDARD SPROTTE NEEDLE
K911202 · Pajunk GmbH · May 1992