Cleared Special

K041970 - BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML

K041970 is an FDA 510(k) clearance for BIOTOP HOOKSAFE 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 12-day FDA review.

K041970 · Biotop Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
12d
Days
Class 2
Risk

K041970 is an FDA 510(k) clearance for the BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 1.... Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Biotop Technology Co., Ltd. (Hsin Chu City, TW). The FDA issued a Cleared decision on August 3, 2004 after a review of 12 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 - K041970

510(k) Number K041970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2004
Decision Date August 03, 2004
Days to Decision 12 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
117d faster than avg
Panel avg: 129d · This submission: 12d
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 K041970.
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
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
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
PERFECT SAFETY SYRINGE
K030604 · Perfect Medical Industry Co., Ltd. · Apr 2004
K041970 · BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML
Download PDF FDA Summary Biotop Technology Co.…