Cleared Traditional

K050243 - IMMEDIA PROTHROMBIN TIME SYSTEM

K050243 is an FDA 510(k) clearance for IMMEDIA PROTHROMBIN TIME SYSTEM, manufactured by Farallon Medial, Inc.. The device is a Class 2 Hematology device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K050243

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
Combination Product No
PCCP Authorized No
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.

JPA Device Classification - Class 2, Special Controls

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 158
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