Cleared Traditional

K131641 - MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)

K131641 is an FDA 510(k) clearance for MONOJECT 60ML SYRINGE (LUER LOCK TIP, manufactured by Nipro Medical Corporation. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K131641 · Nipro Medical Corporation · General Hospital
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Aug 2013
Decision
85d
Days
Class 2
Risk

K131641 is an FDA 510(k) clearance for the MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP). 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 August 28, 2013 after a review of 85 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 Nipro Medical Corporation devices

FDA 510(k) Submission Details - K131641

510(k) Number K131641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2013
Decision Date August 28, 2013
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K131641.
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