Cleared Abbreviated

DRAGON HEART PISTON SYRINGE (K042547) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K042547 · Dragon Heart Medical Devices Co., Ltd. · General Hospital
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Dec 2004
Decision
72d
Days
Class 2
Risk

K042547 is an FDA 510(k) clearance for the DRAGON HEART PISTON SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Dragon Heart Medical Devices Co., Ltd. (Elmhurst, US). The FDA issued a Cleared decision on December 1, 2004 after a review of 72 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Dragon Heart Medical Devices Co., Ltd. devices

Submission Details

510(k) Number K042547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2004
Decision Date December 01, 2004
Days to Decision 72 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 129d · This submission: 72d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FMF Syringe, Piston
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 - FMF Syringe, Piston

All 208
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K042547.
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SMITH & NEPHEW GRAFT DELIVERY SYSTEM
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MERIT MEDICAL 1-ML SYRINGE
K024052 · Merit Medical Systems, Inc. · Feb 2003