Cleared Traditional

BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 (K050367) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K050367 · Hyphen Biomed · Hematology device
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May 2006
Decision
464d
Days
Class 2
Risk

K050367 is an FDA 510(k) clearance for the BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Hyphen Biomed (Mason, US). The FDA issued a Cleared decision on May 24, 2006 after a review of 464 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7525 - the FDA hematology 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 Hematology submissions.

View all Hyphen Biomed devices

Submission Details

510(k) Number K050367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2005
Decision Date May 24, 2006
Days to Decision 464 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
351d slower than avg
Panel avg: 113d · This submission: 464d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KFF Assay, Heparin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7525
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 Hematology devices follow this clearance model.

Regulatory Peers - KFF Assay, Heparin

All 45
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K050367.
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K952667 · Helena Laboratories · Feb 1996
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K935212 · Instrumentation Laboratory CO · Feb 1994