Cleared Traditional

K854149 - TSK STERIJECT STERILE EPIDURAL NEEDLE

K854149 is an FDA 510(k) clearance for TSK STERIJECT STERILE EPIDURAL NEEDLE, manufactured by Pharmacia, Inc.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K854149 · Pharmacia, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1985
Decision
12d
Days
Class 2
Risk

K854149 is an FDA 510(k) clearance for the TSK STERIJECT STERILE EPIDURAL NEEDLE. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on October 23, 1985 after a review of 12 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pharmacia, Inc. devices

FDA 510(k) Submission Details - K854149

510(k) Number K854149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1985
Decision Date October 23, 1985
Days to Decision 12 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
128d faster than avg
Panel avg: 140d · This submission: 12d
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 104
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K854149.
SPINAL TAP NEEDLE
K910652 · Gesco Intl., Inc. · Jul 1991
CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING
K910791 · Kendall Healthcare Products Co. Div.Of Tyco Health · May 1991
SPINAL NEEDLE
K895453 · Advance Medical Designs, Inc. · Oct 1989
VYGON SPINAL ANESTHESIA NEEDLE W/INTRODUCER 183
K851478 · Vygon Corp. · May 1985
AIRES TUOHY NEEDLES 17GA. X 4 1/2
K850111 · Aries Medical, Inc. · Jan 1985
EPINEED EPIDURAL NEEDLE
K832233 · Terumo Medical Corp. · Aug 1983