Cleared Traditional

K051930 - DRUG ACCESS SPIKE

K051930 is an FDA 510(k) clearance for DRUG ACCESS SPIKE, manufactured by Medegen Medical Manufacturing Services. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K051930 · Medegen Medical Manufacturing Services · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
34d
Days
Class 2
Risk

K051930 is an FDA 510(k) clearance for the DRUG ACCESS SPIKE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Medegen Medical Manufacturing Services (Trabuco Canyon, US). The FDA issued a Cleared decision on August 16, 2005 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Medegen Medical Manufacturing Services devices

FDA 510(k) Submission Details - K051930

510(k) Number K051930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2005
Decision Date August 16, 2005
Days to Decision 34 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 129d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 330
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K051930.
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NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
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TERUMO SYRINGE WITH/WITHOUT NEEDLE
K052034 · Terumo Medical Corp. · Aug 2005
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
K051720 · Synthes (Usa) · Jul 2005
STRYKER DISCMONITOR
K050753 · Stryker Instruments · May 2005