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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMF Syringe, Piston

All 552
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K051930.
DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE
K052551 · Devon Safety Products, Inc. · Sep 2005
YI XIN STERILE SYRINGE FOR SINGLE USE
K050999 · Jiangxi Sanxin (Eversincere) Medical Devices Group · Sep 2005
NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
K051574 · Nipro Medical Corp. · Aug 2005
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K052034 · Terumo Medical Corp. · Aug 2005
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
K051720 · Synthes (Usa) · Jul 2005
CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063
K050998 · Confluent Surgical,Inc · Jun 2005

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.