Cleared Traditional

K030683 - NIPRO DISPOSABLE SYRINGES

K030683 is the FDA 510(k) clearance for NIPRO DISPOSABLE SYRINGES by Nipro Medical Corp.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K030683 · Nipro Medical Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 2003
Decision
240d
Days
Class 2
Risk

K030683 is an FDA 510(k) clearance for the NIPRO DISPOSABLE SYRINGES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Nipro Medical Corp. (Lexington, US). The FDA issued a Cleared decision on October 31, 2003 after a review of 240 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 Medical Corp. devices

Submission Details

510(k) Number K030683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2003
Decision Date October 31, 2003
Days to Decision 240 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
111d slower than avg
Panel avg: 129d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - FMF Syringe, Piston

All 313
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K030683.
MAGELLAN RATIO DISPENSER KIT
K041830 · Medtronic Perfusion Systems · Sep 2004
SMITH & NEPHEW GRAFT DELIVERY SYSTEM
K041976 · Smith & Nephew, Inc. · Aug 2004
VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
K033721 · Vascular Solutions, Inc. · Feb 2004
MERIT MEDICAL 1-ML SYRINGE
K024052 · Merit Medical Systems, Inc. · Feb 2003
BD INSULIN SYRINGE
K024112 · Becton, Dickinson & CO · Jan 2003
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K023271 · Terumo Medical Corp. · Dec 2002