Cleared Abbreviated

K042547 - DRAGON HEART PISTON SYRINGE

K042547 is an FDA 510(k) clearance for DRAGON HEART PISTON SYRINGE, manufactured by Dragon Heart Medical Devices Co., Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Abbreviated 510(k) pathway after a 72-day FDA review.

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.

FDA 510(k) Submission Details - K042547

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 129d · This submission: 72d
Pathway characteristics
Standards-based clearance path.

FMF Device Classification - Class 2, Special Controls

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 726
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K042547.
PROCEDUR 10 SYRINGE DEVICE
K042486 · Avanca Medical Devices, Inc. · Jan 2005
TRUGRAFT BGS SYRINGE, MODEL 600-041
K043172 · Osteobiologics, Inc. · Jan 2005
CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093
K042588 · Confluent Surgical,Inc · Dec 2004
SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE
K042314 · Biogen · Nov 2004
1BD SOLOSHOT IX SYRINGE
K042934 · Becton, Dickinson & CO · Oct 2004
BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR
K033589 · Micromedics, Inc. · Oct 2004
K042547 · DRAGON HEART PISTON SYRINGE
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