Cleared Traditional

K051574 - NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE

K051574 is an FDA 510(k) clearance for NIPRO DISPOSABLE SYRINGE WITH OR WITHOU..., 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 73-day FDA review.

K051574 · Nipro Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
73d
Days
Class 2
Risk

K051574 is an FDA 510(k) clearance for the NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE. 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 August 26, 2005 after a review of 73 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 Corp. devices

FDA 510(k) Submission Details - K051574

510(k) Number K051574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2005
Decision Date August 26, 2005
Days to Decision 73 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
56d faster than avg
Panel avg: 129d · This submission: 73d
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 524
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K051574.
VITAGEL SURGICAL HEMOSTAT SPRAY SET
K052173 · Orthovita, Inc. · Oct 2005
DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE
K052551 · Devon Safety Products, Inc. · Sep 2005
YI XIN STERILE SYRINGE FOR SINGLE USE
K050999 · Jiangxi Sanxin (Eversincere) Medical Devices Group · Sep 2005
DRUG ACCESS SPIKE
K051930 · Medegen Medical Manufacturing Services · Aug 2005
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K052034 · Terumo Medical Corp. · Aug 2005
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
K051720 · Synthes (Usa) · Jul 2005