Cleared Traditional

K874579 - COEUR CONTROL SYRINGE

K874579 is an FDA 510(k) clearance for COEUR CONTROL SYRINGE, manufactured by Coeur Laboratories, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K874579 · Coeur Laboratories, Inc. · General Hospital
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Jan 1988
Decision
74d
Days
Class 2
Risk

K874579 is an FDA 510(k) clearance for the COEUR CONTROL SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Coeur Laboratories, Inc. (Raleigh, US). The FDA issued a Cleared decision on January 19, 1988 after a review of 74 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.

FDA 510(k) Submission Details - K874579

510(k) Number K874579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1987
Decision Date January 19, 1988
Days to Decision 74 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
55d faster than avg
Panel avg: 129d · This submission: 74d
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 755
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K874579.
MEDICRAT, HYPODERMIC SYRINGES & NEEDLES
K875148 · Knowltech Ind., Inc. · Feb 1988
10CC SYRINGE CONTROL RING SET
K874747 · Procedure Products, Inc. · Feb 1988
EXTRAVAKIT
K874807 · Cancer Technologies, Inc. · Feb 1988
DUOFLO DISPENSER
K872565 · Hemaedics, Inc. · Dec 1987
CUSTOM PROCEDURE TRAYS
K871616 · Medical Custom Products, Inc. · Dec 1987
3 RING ATTACHMENT FOR SYRINGES
K873709 · Condor Medical · Nov 1987
K874579 · COEUR CONTROL SYRINGE
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