Cleared Traditional

K960405 - SPINAL NEEDLE

K960405 is an FDA 510(k) clearance for SPINAL NEEDLE, manufactured by Promex, Inc.. The device is a Class 2 Anesthesiology device with product code MIA cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K960405 · Promex, Inc. · Anesthesiology device
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Feb 1996
Decision
30d
Days
Class 2
Risk

K960405 is an FDA 510(k) clearance for the SPINAL NEEDLE. Classified as Needle, Spinal, Short Term (product code MIA), Class II - Special Controls.

Submitted by Promex, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 28, 1996 after a review of 30 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 Promex, Inc. devices

FDA 510(k) Submission Details - K960405

510(k) Number K960405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1996
Decision Date February 28, 1996
Days to Decision 30 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MIA Device Classification - Class 2, Special Controls

Product Code MIA Needle, Spinal, Short Term
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 - MIA Needle, Spinal, Short Term

Devices cleared under the same product code (MIA) and FDA review panel - the closest regulatory comparables to K960405.
Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors
K172800 · Smiths Medical Asd, Inc. · Jun 2018
CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA
K982269 · Allegiance Healthcare Corp. · Jul 1998
ACUFEX T-FIX DELIVERY SYSTEM
K942442 · Acufex Microsurgical, Inc. · Dec 1994