Cleared Special

K023323 - 1CC FUTURA SAFETY SYRINGE

K023323 is an FDA 510(k) clearance for 1CC FUTURA SAFETY SYRINGE, manufactured by Futura Medical Technology. The device is a Class 2 General Hospital device with product code MEG cleared through the Special 510(k) pathway after a 25-day FDA review.

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.

FDA 510(k) Submission Details - K023323

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

MEG Device Classification - Class 2, Special Controls

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 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K023323.
TERUMO SURGUARD SAFETY SYRINGE
K024249 · Terumo Medical Corp. · Feb 2003
EXEL SECURETOUCH PTP SYRINGE
K011754 · Exelint Intl. Co. · Jan 2003
TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)
K023458 · Taiject Medical Device Co., Ltd. · Nov 2002
DUOPRO SAFETY SYRINGE (DUOPROSS)
K022806 · M.K. Meditech Co. , Ltd. · Sep 2002
TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML)
K022278 · Taiject Medical Device Co., Ltd. · Sep 2002
SAFEPRO SAFETY SYRINGE
K022063 · Formosa Medical Devices, Inc. · Aug 2002
K023323 · 1CC FUTURA SAFETY SYRINGE
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