Cleared Abbreviated

K101368 - D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES

K101368 is an FDA 510(k) clearance for D. HEART MEDICAL INTRAVASCULAR ADMINIST..., manufactured by Dragon Heart Medical, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Abbreviated 510(k) pathway after a 185-day FDA review.

K101368 · Dragon Heart Medical, Inc. · General Hospital
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Nov 2010
Decision
185d
Days
Class 2
Risk

K101368 is an FDA 510(k) clearance for the D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND AC.... Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Dragon Heart Medical, Inc. (Bensenville, US). The FDA issued a Cleared decision on November 18, 2010 after a review of 185 days - an extended review cycle.

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, Inc. devices

FDA 510(k) Submission Details - K101368

510(k) Number K101368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2010
Decision Date November 18, 2010
Days to Decision 185 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
56d slower than avg
Panel avg: 129d · This submission: 185d
Pathway characteristics
Standards-based clearance path.

FPA Device Classification - Class 2, Special Controls

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 646
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K101368.
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