Cleared Traditional

K013231 - AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
72d faster than avg
Panel avg: 139d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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)

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