Cleared Traditional

BIFURCATED VACCINATING NEEDLE (K012515) - FDA 510(k) Clearance

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

K012515 · Precision Medical Products, Inc. · General Hospital
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Sep 2001
Decision
44d
Days
Class 2
Risk

K012515 is an FDA 510(k) clearance for the BIFURCATED VACCINATING NEEDLE. Classified as Allergen And Vaccine Delivery Needles (product code SCL), Class II - Special Controls.

Submitted by Precision Medical Products, Inc. (Denver, US). The FDA issued a Cleared decision on September 19, 2001 after a review of 44 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital 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 Precision Medical Products, Inc. devices

Submission Details

510(k) Number K012515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2001
Decision Date September 19, 2001
Days to Decision 44 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 129d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SCL Allergen And Vaccine Delivery Needles
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
Definition An Allergen Delivery Needle Is A Device Intended To Percutaneously Deliver Diagnostic Allergenic Extracts For Use In Allergy Skin Tests Also Referred To As Skin Prick Tests Or Intradermal Allergy Tests.
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 General Hospital devices follow this clearance model.

Regulatory Peers - SCL Allergen And Vaccine Delivery Needles

Devices cleared under the same product code (SCL) and FDA review panel - the closest regulatory comparables to K012515.
Oryum and Ovem Epidermal Deri Prick Test Applicator
K182582 · Allergy & Applicator Depot, LLC · Apr 2019
AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray
K172062 · Medscience Science Research Group, Inc. · Mar 2018
BD ECLIPSE BIFURCATED NEEDLE
K032528 · Becton, Dickinson & CO · Sep 2003