Cleared Abbreviated

Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use (K201284) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K201284 · Set Medikal Sanayi VE Ticaret Anonim Sirketi · General Hospital
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Dec 2020
Decision
215d
Days
Class 2
Risk

K201284 is an FDA 510(k) clearance for the Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-loc.... Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Set Medikal Sanayi VE Ticaret Anonim Sirketi (Istanbul, TR). The FDA issued a Cleared decision on December 14, 2020 after a review of 215 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Set Medikal Sanayi VE Ticaret Anonim Sirketi devices

Submission Details

510(k) Number K201284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2020
Decision Date December 14, 2020
Days to Decision 215 days
Submission Type Abbreviated
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
86d slower than avg
Panel avg: 129d · This submission: 215d
Pathway characteristics
Standards-based clearance path.

Device Classification

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

Medcer Uluslararasi Medikal Belgelendirme Anonim Sirketi
Mehmet Fatih Ormeci

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 241
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K201284.
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