Cleared Traditional

K120641 - GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE

K120641 is an FDA 510(k) clearance for GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY..., manufactured by Global Medi Products. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K120641 · Global Medi Products · General Hospital
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Oct 2012
Decision
229d
Days
Class 2
Risk

K120641 is an FDA 510(k) clearance for the GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Global Medi Products (Buffalo, US). The FDA issued a Cleared decision on October 17, 2012 after a review of 229 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Global Medi Products devices

FDA 510(k) Submission Details - K120641

510(k) Number K120641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2012
Decision Date October 17, 2012
Days to Decision 229 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 129d · This submission: 229d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEG Device Classification - Class 2, Special Controls

Product Code MEG Syringe, Antistick
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 - MEG Syringe, Antistick

All 114
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K120641.
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