Cleared Traditional

K050243 - IMMEDIA PROTHROMBIN TIME SYSTEM

K050243 is the FDA 510(k) clearance for IMMEDIA PROTHROMBIN TIME SYSTEM by Farallon Medial, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K050243 · Farallon Medial, Inc. · Hematology device
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Jun 2005
Decision
124d
Days
Class 2
Risk

K050243 is an FDA 510(k) clearance for the IMMEDIA PROTHROMBIN TIME SYSTEM. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Farallon Medial, Inc. (Hayward, US). The FDA issued a Cleared decision on June 6, 2005 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Farallon Medial, Inc. devices

Submission Details

510(k) Number K050243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2005
Decision Date June 06, 2005
Days to Decision 124 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 113d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 117
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K050243.
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