Cleared Special

K130049 - MONOJECT 12ML SYRINGE

K130049 is an FDA 510(k) clearance for MONOJECT 12ML SYRINGE, manufactured by Nipro Medical Corporation. The device is a Class 2 General Hospital device with product code FMF cleared through the Special 510(k) pathway after a 37-day FDA review.

K130049 · Nipro Medical Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
37d
Days
Class 2
Risk

K130049 is an FDA 510(k) clearance for the MONOJECT 12ML SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on February 14, 2013 after a review of 37 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.

View all Nipro Medical Corporation devices

FDA 510(k) Submission Details - K130049

510(k) Number K130049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2013
Decision Date February 14, 2013
Days to Decision 37 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
92d faster than avg
Panel avg: 129d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

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 480
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K130049.
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