Cleared Special

K042426 - TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN)

K042426 is an FDA 510(k) clearance for TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0..., 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 14-day FDA review.

K042426 · 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
Sep 2004
Decision
14d
Days
Class 2
Risk

K042426 is an FDA 510(k) clearance for the TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SE.... Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Taiject Medical Device Co., Ltd. (Newport Beach, US). The FDA issued a Cleared decision on September 22, 2004 after a review of 14 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 - K042426

510(k) Number K042426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2004
Decision Date September 22, 2004
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
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 K042426.
PROCEDUR SF SAFETY SYRINGE DEVICE
K042487 · Avanca Medical Devices, Inc. · Jan 2005
BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML
K043038 · Biotop Technology Co., Ltd. · Dec 2004
TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM
K042712 · Safety Syringes, Inc. · Oct 2004
BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML
K041970 · Biotop Technology Co., Ltd. · Aug 2004
MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRINGE WITH HYPODERMIC NEEDLE
K032517 · Medsafe Technologies, LLC · May 2004
BIOTOP DJT-A SAFETY SYRINGE
K032747 · Biotop Technology Co., Ltd. · May 2004
K042426 · TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN)
Download PDF FDA Summary Taiject Medical Devic…