Cleared Traditional

K851478 - VYGON SPINAL ANESTHESIA NEEDLE W/INTROD...

K851478 is an FDA 510(k) clearance for VYGON SPINAL ANESTHESIA NEEDLE W/INTROD..., manufactured by Vygon Corp.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K851478 · Vygon Corp. · Anesthesiology device
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May 1985
Decision
22d
Days
Class 2
Risk

K851478 is an FDA 510(k) clearance for the VYGON SPINAL ANESTHESIA NEEDLE W/INTRODUCER 183. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Vygon Corp. (East Rutherford, US). The FDA issued a Cleared decision on May 7, 1985 after a review of 22 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 Vygon Corp. devices

FDA 510(k) Submission Details - K851478

510(k) Number K851478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1985
Decision Date May 07, 1985
Days to Decision 22 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
118d faster than avg
Panel avg: 140d · This submission: 22d
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 K851478.
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
EPINEED EPIDURAL NEEDLE
K832233 · Terumo Medical Corp. · Aug 1983
MONOJECT PLASTIC HUB SPINAL NEEDLE
K822630 · Sherwood Medical Co. · Oct 1982
SPINOCAN SPINAL NEEDLE
K820047 · Burron Medical Products, Inc. · Jan 1982