Cleared Traditional

K964230 - CORELIFE

K964230 is an FDA 510(k) clearance for CORELIFE, manufactured by Core Healthcare , Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K964230 · Core Healthcare , Ltd. · General Hospital
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Jul 1997
Decision
274d
Days
Class 2
Risk

K964230 is an FDA 510(k) clearance for the CORELIFE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Core Healthcare , Ltd. (Battle Creek, US). The FDA issued a Cleared decision on July 24, 1997 after a review of 274 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 Core Healthcare , Ltd. devices

FDA 510(k) Submission Details - K964230

510(k) Number K964230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1996
Decision Date July 24, 1997
Days to Decision 274 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 129d · This submission: 274d
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 556
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K964230.
ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300
K972878 · Safety Syringes, Inc. · Oct 1997
BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE
K964597 · Biosurgical Corp. · Sep 1997
RAMY PISTON SYRINGE
K971664 · Alshifa Medical Syringes Mfg. Co., Ltd. · Jul 1997
RAMY INTEGRATED NEEDLE SYRINGE
K972452 · Alshifa Medical Syringes Mfg. Co., Ltd. · Jul 1997
BRANNON ARTERIO-VENOUS PORTSYRINGE
K965030 · Vascular Logics, Inc. · Mar 1997
OMNICAN SYRINGE
K962084 · B. Braun Medical AG · Feb 1997