Cleared Traditional

K832233 - EPINEED EPIDURAL NEEDLE

K832233 is an FDA 510(k) clearance for EPINEED EPIDURAL NEEDLE, manufactured by Terumo Medical Corp.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K832233 · Terumo Medical Corp. · Anesthesiology device
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Aug 1983
Decision
28d
Days
Class 2
Risk

K832233 is an FDA 510(k) clearance for the EPINEED EPIDURAL NEEDLE. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on August 8, 1983 after a review of 28 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K832233

510(k) Number K832233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1983
Decision Date August 08, 1983
Days to Decision 28 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
112d faster than avg
Panel avg: 140d · This submission: 28d
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 72
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K832233.
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
MONOJECT PLASTIC HUB SPINAL NEEDLE
K822630 · Sherwood Medical Co. · Oct 1982
SPINOCAN SPINAL NEEDLE
K820047 · Burron Medical Products, Inc. · Jan 1982
PLEXUFIX BRACHIAL PLEXUS ANESTH. NEEDLE
K813165 · Burron Medical Products, Inc. · Dec 1981