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)
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.

View all Biotop Technology Co., Ltd. devices

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
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 56
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K032747.
PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
K063755 · Smiths Medical Asd, Inc. · Feb 2007
PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558
K061194 · Smiths Medical Asd, Inc. · Aug 2006
TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR
K051865 · Terumo Medical Corp. · Sep 2005
TERUMO SURGUARD SAFETY SYRINGE
K024249 · Terumo Medical Corp. · Feb 2003
UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
K993996 · Univec, Inc. · Jul 2000
SOLOGUARD LOCKING PLUS SYRINGE
K993609 · Safeguard Medical Products, Inc. · Mar 2000