Cleared Traditional

K012515 - BIFURCATED VACCINATING NEEDLE

K012515 is an FDA 510(k) clearance for BIFURCATED VACCINATING NEEDLE, manufactured by Precision Medical Products, Inc.. The device is a Class 2 General Hospital device with product code SCL cleared through the Traditional 510(k) pathway after a 44-day FDA review.

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.

FDA 510(k) Submission Details - K012515

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
Combination Product No
PCCP Authorized No
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.

SCL Device Classification - Class 2, Special Controls

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

All 24
Devices cleared under the same product code (SCL) and FDA review panel - the closest regulatory comparables to K012515.
BIFURCATED ALLERGY SKIN TESTING NEEDLE
K031630 · Precision Medical Products, Inc. · Aug 2003
BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757
K020523 · Bd · Mar 2002
UNIVEC BIFURCATED SLIDING SHEATH SYRINGE
K020500 · Univec, Inc. · Mar 2002
ALLERSHARP ALLERGY SKIN TESTER
K011979 · Hmb Medical Concepts, Ltd. · Sep 2001
GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC
K003195 · Greer Laboratories, Inc. · Dec 2000
DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D
K000299 · Biomedex, Inc. · Apr 2000
K012515 · BIFURCATED VACCINATING NEEDLE
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