Cleared Traditional

K902178 - YUEFA DISPOSABLE SYRINGE

K902178 is an FDA 510(k) clearance for YUEFA DISPOSABLE SYRINGE, manufactured by Blue & Red Corp.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K902178 · Blue & Red Corp. · General Hospital
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Dec 1990
Decision
220d
Days
Class 2
Risk

K902178 is an FDA 510(k) clearance for the YUEFA DISPOSABLE SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Blue & Red Corp. (Merrick, US). The FDA issued a Cleared decision on December 21, 1990 after a review of 220 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 Blue & Red Corp. devices

FDA 510(k) Submission Details - K902178

510(k) Number K902178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1990
Decision Date December 21, 1990
Days to Decision 220 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 129d · This submission: 220d
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 539
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K902178.
BECTON DICKINSON SAFETY-LOK SYRINGE
K920321 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH
K913235 · Davol, Inc. · Oct 1991
B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #328204
K912330 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
JOHNSON & JOHNSON DUAL SYRINGE APPLICATOR
K902157 · Johnson & Johnson Medical, Inc. · Nov 1990
DISPOSABLE CORONARY CONTROL SYRINGE
K902346 · Advance Medical Designs, Inc. · Jun 1990
AUTOPEN
K895890 · Ulster Scientific, Inc. · Feb 1990