Cleared Special

1CC FUTURA SAFETY SYRINGE (K023323) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K023323 · Futura Medical Technology · General Hospital
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Oct 2002
Decision
25d
Days
Class 2
Risk

K023323 is an FDA 510(k) clearance for the 1CC FUTURA SAFETY SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Futura Medical Technology (Solana Beach, US). The FDA issued a Cleared decision on October 29, 2002 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K023323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2002
Decision Date October 29, 2002
Days to Decision 25 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MEG Syringe, Antistick
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 - MEG Syringe, Antistick

All 37
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K023323.
Greenmedi Safety Filter Syringe
K173743 · Sang-A Frontec Co., Ltd. · Jan 2019
Self-destruction Safety Syringes for Single Use
K180417 · Berpu Medical Technology Co., Ltd. · Aug 2018
MEDLINE RETRACTABLE SAFETY SYRINGE
K101560 · Medline Industries, Inc. · Mar 2011
BECTON DICKINSON SYRINGE
K992734 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1999
HYPO(R) SAFETY CARTRIDGE SYRINGE
K936040 · Smith & Nephew, Inc. · May 1995