Cleared Abbreviated

DRAGON HEART I.V. SET (K043235) - FDA 510(k) Clearance

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

K043235 · Dragon Heart Medical Devices Co., Ltd. · General Hospital
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Mar 2005
Decision
106d
Days
Class 2
Risk

K043235 is an FDA 510(k) clearance for the DRAGON HEART I.V. SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Dragon Heart Medical Devices Co., Ltd. (Elmhurst, US). The FDA issued a Cleared decision on March 8, 2005 after a review of 106 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 K043235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2004
Decision Date March 08, 2005
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 208
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