Cleared Special

K023458 - TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)

K023458 is an FDA 510(k) clearance for TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA..., manufactured by Taiject Medical Device Co., Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Special 510(k) pathway after a 23-day FDA review.

K023458 · Taiject Medical Device Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
23d
Days
Class 2
Risk

K023458 is an FDA 510(k) clearance for the TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML). Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Taiject Medical Device Co., Ltd. (Irvine, US). The FDA issued a Cleared decision on November 7, 2002 after a review of 23 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 - K023458

510(k) Number K023458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2002
Decision Date November 07, 2002
Days to Decision 23 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 129d · This submission: 23d
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 K023458.
TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN)
K031062 · Taiject Medical Device Co., Ltd. · May 2003
TERUMO SURGUARD SAFETY SYRINGE
K024249 · Terumo Medical Corp. · Feb 2003
EXEL SECURETOUCH PTP SYRINGE
K011754 · Exelint Intl. Co. · Jan 2003
1CC FUTURA SAFETY SYRINGE
K023323 · Futura Medical Technology · Oct 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
K023458 · TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)
Download PDF FDA Summary Taiject Medical Devic…