Cleared Traditional

K903224 - EPISENSOR

K903224 is an FDA 510(k) clearance for EPISENSOR, manufactured by Palex Intl. SA. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K903224 · Palex Intl. SA · Anesthesiology device
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Dec 1990
Decision
154d
Days
Class 2
Risk

K903224 is an FDA 510(k) clearance for the EPISENSOR. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Palex Intl. SA (Spain, ES). The FDA issued a Cleared decision on December 24, 1990 after a review of 154 days - an extended review 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: 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 Palex Intl. SA devices

FDA 510(k) Submission Details - K903224

510(k) Number K903224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1990
Decision Date December 24, 1990
Days to Decision 154 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 140d · This submission: 154d
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 121
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K903224.
ATRAUMATIC STANDARD SPROTTE NEEDLE
K911260 · Pajunk GmbH · Oct 1991
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
TSK STERIJECT STERILE EPIDURAL NEEDLE
K854149 · Pharmacia, Inc. · Oct 1985
VYGON SPINAL ANESTHESIA NEEDLE W/INTRODUCER 183
K851478 · Vygon Corp. · May 1985