Cleared Traditional

K983430 - LITE-TOUCH SYRINGE

K983430 is the FDA 510(k) clearance for LITE-TOUCH SYRINGE by Medicore, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K983430 · Medicore, Inc. · General Hospital
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Feb 1999
Decision
133d
Days
Class 2
Risk

K983430 is an FDA 510(k) clearance for the LITE-TOUCH SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Medicore, Inc. (Hialeah, US). The FDA issued a Cleared decision on February 9, 1999 after a review of 133 days - within the typical 510(k) review window.

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 Medicore, Inc. devices

Submission Details

510(k) Number K983430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1998
Decision Date February 09, 1999
Days to Decision 133 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 129d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 292
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K983430.
TERUMO U-100 INSULIN SYRINGE
K992802 · Terumo Medical Corp. · Sep 1999
MTI 1 ML SYRINGE
K991225 · Micro Therapeutics, Inc. · Jul 1999
MONOJECT INSULIN SYRINGE
K991758 · The Kendal Co. · Jun 1999
STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)
K972728 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1998
BECTON DICKINSON SYRINGES
K980580 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998
B-D PEN ULTRA
K981797 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998