Cleared Special

K111734 - MYSAFETY SYRINGE

K111734 is an FDA 510(k) clearance for MYSAFETY SYRINGE, manufactured by Medicalchain Intl. Corp.. The device is a Class 2 General Hospital device with product code MEG cleared through the Special 510(k) pathway after a 77-day FDA review.

K111734 · Medicalchain Intl. Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
77d
Days
Class 2
Risk

K111734 is an FDA 510(k) clearance for the MYSAFETY SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Medicalchain Intl. Corp. (Thousand Oaks, US). The FDA issued a Cleared decision on September 6, 2011 after a review of 77 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K111734

510(k) Number K111734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2011
Decision Date September 06, 2011
Days to Decision 77 days
Submission Type Special
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
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

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 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K111734.
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K101233 · Rexam Pharma · Feb 2011
MED-LOK SAFETY NEEDLE
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K111734 · MYSAFETY SYRINGE
Download PDF FDA Summary Medicalchain Intl. Co…