Cleared Traditional

K013231 - AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE

K013231 is an FDA 510(k) clearance for AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE, 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 67-day FDA review.

K013231 · Avid N.I.T., Inc. · Anesthesiology device
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Dec 2001
Decision
67d
Days
Class 2
Risk

K013231 is an FDA 510(k) clearance for the AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB L.... Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Avid N.I.T., Inc. (Oldsmar, US). The FDA issued a Cleared decision on December 3, 2001 after a review of 67 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 - K013231

510(k) Number K013231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2001
Decision Date December 03, 2001
Days to Decision 67 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
73d faster than avg
Panel avg: 140d · This submission: 67d
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 K013231.
SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)
K061394 · Busse Hospital Disposables, Inc. · Sep 2006
WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
K030618 · Wilson-Cook Medical, Inc. · May 2003
PERIFIX SAFETY EPIDURAL NEEDLES
K013610 · B.Braun Medical, Inc. · Jan 2002
BALLPEN SPINAL NEEDLE W/WO INTRODUCER
K011122 · Rusch Intl. · Nov 2001
MANAN SPRITACRE SPINAL NEEDLES
K011209 · Manan Medical Products, Inc. · Jun 2001
MANAN SPINAL NEEDLES
K983620 · Manan Medical Products, Inc. · Jan 1999