Cleared Special

K043038 - BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML

K043038 is an FDA 510(k) clearance for BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, manufactured by Biotop Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Special 510(k) pathway after a 48-day FDA review.

K043038 · Biotop Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
48d
Days
Class 2
Risk

K043038 is an FDA 510(k) clearance for the BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Biotop Technology Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on December 22, 2004 after a review of 48 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 - K043038

510(k) Number K043038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2004
Decision Date December 22, 2004
Days to Decision 48 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
81d faster than avg
Panel avg: 129d · This submission: 48d
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 K043038.
ICC INSULIN SAFEPRO SAFETY SYRINGE
K050134 · Formosa Medical Devices, Inc. · Apr 2005
YIXIN SAFETY SYRINGE
K042102 · Jiangxi Sanxin (Eversincere) Medical Devices Group · Mar 2005
PROCEDUR SF SAFETY SYRINGE DEVICE
K042487 · Avanca Medical Devices, Inc. · Jan 2005
TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM
K042712 · Safety Syringes, Inc. · Oct 2004
TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN)
K042426 · Taiject Medical Device Co., Ltd. · Sep 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
K043038 · BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML
Download PDF FDA Summary Biotop Technology Co.…