Cleared Traditional

K032747 - BIOTOP DJT-A SAFETY SYRINGE

K032747 is an FDA 510(k) clearance for BIOTOP DJT-A SAFETY SYRINGE, manufactured by Biotop Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K032747 · Biotop Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
250d
Days
Class 2
Risk

K032747 is an FDA 510(k) clearance for the BIOTOP DJT-A SAFETY SYRINGE. 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 May 11, 2004 after a review of 250 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K032747

510(k) Number K032747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2003
Decision Date May 11, 2004
Days to Decision 250 days
Submission Type Traditional
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
121d slower than avg
Panel avg: 129d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K032747.
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
MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRINGE WITH HYPODERMIC NEEDLE
K032517 · Medsafe Technologies, LLC · May 2004
PERFECT SAFETY SYRINGE
K030604 · Perfect Medical Industry Co., Ltd. · Apr 2004
OTTER SAFETY SYRINGE
K040545 · Otter (China) Technology Co., Ltd. · Apr 2004
YUE PFONG SAFETY SYRINGE (3ML)
K040105 · Yue Pfong International Industrial Co., Ltd. · Apr 2004
K032747 · BIOTOP DJT-A SAFETY SYRINGE
Download PDF FDA Summary Biotop Technology Co.…