Cleared Traditional

K972595 - ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER

K972595 is an FDA 510(k) clearance for ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER, manufactured by Avid N.I.T., Inc.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K972595 · Avid N.I.T., Inc. · Anesthesiology device
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May 1998
Decision
313d
Days
Class 2
Risk

K972595 is an FDA 510(k) clearance for the ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Avid N.I.T., Inc. (Tarpon Springs, US). The FDA issued a Cleared decision on May 20, 1998 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Avid N.I.T., Inc. devices

FDA 510(k) Submission Details - K972595

510(k) Number K972595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1997
Decision Date May 20, 1998
Days to Decision 313 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
173d slower than avg
Panel avg: 140d · This submission: 313d
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 69
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K972595.
MANAN SPRITACRE SPINAL NEEDLES
K011209 · Manan Medical Products, Inc. · Jun 2001
MANAN SPINAL NEEDLES
K983620 · Manan Medical Products, Inc. · Jan 1999
EPIDURAL NEEDLE
K980536 · Manan Medical Products, Inc. · Jul 1998
CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA.
K951949 · Baxter Healthcare Corp · Aug 1995
MONOJECT WHITACRE POINT SPINAL NEEDLE (27G X 3 1/2)
K951312 · Sherwood Medical Co. · May 1995
MONOJECT TUOHY POINT EPIDURAL NEEDLE (22G X 3 1/2)
K951411 · Sherwood Medical Co. · May 1995