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
Combination Product No
PCCP Authorized No
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 Consultant

Spectra Medical Devices, Inc.
Kathy Dassler

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MIA Needle, Spinal, Short Term

All 8
Devices cleared under the same product code (MIA) and FDA review panel - the closest regulatory comparables to K971645.
FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837
K051860 · Epimed International, Inc. · Aug 2005
SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES
K983858 · Sims Portex, Inc. · Jan 1999
CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA
K982269 · Allegiance Healthcare Corp. · Jul 1998
NEO-CARE LUMBER PUNCTURE KIT
K970997 · Klein-Baker Medical, Inc. · May 1997
GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES
K961324 · Global Medical Prods, Inc. · Jul 1996
SPINAL NEEDLE
K960405 · Promex, Inc. · Feb 1996