Cleared Traditional

K971645 - REGANES SPINAL NEEDLE (VARIOUS)

K971645 is an FDA 510(k) clearance for REGANES SPINAL NEEDLE (VARIOUS), manufactured by Avid N.I.T., Inc.. The device is a Class 2 Anesthesiology device with product code MIA cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K971645 · Avid N.I.T., Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
88d
Days
Class 2
Risk

K971645 is an FDA 510(k) clearance for the REGANES SPINAL NEEDLE (VARIOUS). Classified as Needle, Spinal, Short Term (product code MIA), Class II - Special Controls.

Submitted by Avid N.I.T., Inc. (Tarpon Springs, US). The FDA issued a Cleared decision on August 1, 1997 after a review of 88 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 Avid N.I.T., Inc. devices

FDA 510(k) Submission Details - K971645

510(k) Number K971645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1997
Decision Date August 01, 1997
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 140d · This submission: 88d
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 K971645.
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