Cleared Traditional

K030683 - NIPRO DISPOSABLE SYRINGES

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

K030683 · Nipro Medical Corp. · General Hospital
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K030683

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.

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 523
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K030683.
CLIP-ON SPACER 20%
K041084 · Serono, Inc. · Jul 2004
AUTODETECT SYRINGE
K041590 · Indigo Orb, Inc. · Jun 2004
VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
K033721 · Vascular Solutions, Inc. · Feb 2004
IMBIBE II SYRINGE
K030208 · Orthovita, Inc. · Apr 2003
IMBIBE BONE MARROW ASPIRATION SYRINGE
K023074 · Orthovita, Inc. · Mar 2003
MERIT MEDICAL 1-ML SYRINGE
K024052 · Merit Medical Systems, Inc. · Feb 2003