Cleared Traditional

K014114 - GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX

K014114 is an FDA 510(k) clearance for GLUCOPRO SYRINGE, manufactured by Nipro Diabetes Systems, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K014114 · Nipro Diabetes Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
194d
Days
Class 2
Risk

K014114 is an FDA 510(k) clearance for the GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Nipro Diabetes Systems, Inc. (Lexington, US). The FDA issued a Cleared decision on June 26, 2002 after a review of 194 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 Nipro Diabetes Systems, Inc. devices

FDA 510(k) Submission Details - K014114

510(k) Number K014114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2001
Decision Date June 26, 2002
Days to Decision 194 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 129d · This submission: 194d
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 388
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K014114.
BONE GRAFT SYRINGE, MODEL 8600-00X0
K023088 · Wrightmedicaltechnologyinc · Oct 2002
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
K022246 · Depuyacromed · Aug 2002
PCCS GRAFT DELIVERY SYSTEM
K021071 · Biomet, Inc. · Jul 2002
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
K020666 · Baxter Healthcare Corp · Jun 2002
DUPLOREACH
K014088 · Baxter Healthcare Corp · Jun 2002
MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP
K020147 · Medtronic Perfusion Systems · Apr 2002