Cleared Traditional

K030604 - PERFECT SAFETY SYRINGE

K030604 is an FDA 510(k) clearance for PERFECT SAFETY SYRINGE, manufactured by Perfect Medical Industry Co., Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 430-day FDA review.

K030604 · Perfect Medical Industry Co., Ltd. · General Hospital
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Apr 2004
Decision
430d
Days
Class 2
Risk

K030604 is an FDA 510(k) clearance for the PERFECT SAFETY SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Perfect Medical Industry Co., Ltd. (Plano, US). The FDA issued a Cleared decision on April 30, 2004 after a review of 430 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

FDA 510(k) Submission Details - K030604

510(k) Number K030604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2003
Decision Date April 30, 2004
Days to Decision 430 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
301d slower than avg
Panel avg: 129d · This submission: 430d
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 K030604.
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
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
INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 102905
K040036 · Inviro Medical · Mar 2004
K030604 · PERFECT SAFETY SYRINGE
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