Cleared Traditional

K971664 - RAMY PISTON SYRINGE

K971664 is an FDA 510(k) clearance for RAMY PISTON SYRINGE, manufactured by Alshifa Medical Syringes Mfg. Co., Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K971664 · Alshifa Medical Syringes Mfg. Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 1997
Decision
80d
Days
Class 2
Risk

K971664 is an FDA 510(k) clearance for the RAMY PISTON SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Alshifa Medical Syringes Mfg. Co., Ltd. (Great Neck,, US). The FDA issued a Cleared decision on July 25, 1997 after a review of 80 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 Alshifa Medical Syringes Mfg. Co., Ltd. devices

FDA 510(k) Submission Details - K971664

510(k) Number K971664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1997
Decision Date July 25, 1997
Days to Decision 80 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
49d faster than avg
Panel avg: 129d · This submission: 80d
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 389
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K971664.
DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)
K973510 · Immuno-U.S., Inc. · Dec 1997
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K972878 · Safety Syringes, Inc. · Oct 1997
BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE
K964597 · Biosurgical Corp. · Sep 1997
RAMY INTEGRATED NEEDLE SYRINGE
K972452 · Alshifa Medical Syringes Mfg. Co., Ltd. · Jul 1997
BRANNON ARTERIO-VENOUS PORTSYRINGE
K965030 · Vascular Logics, Inc. · Mar 1997
IRT LOCKING SYRINGE
K945410 · Interventional Research Technologies · Dec 1996