Cleared Traditional

K851153 - COATRON F(SAME AS COATRON

K851153 is the FDA 510(k) clearance for COATRON F(SAME AS COATRON by Astral Medical Systems. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K851153 · Astral Medical Systems · Hematology device
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Nov 1985
Decision
228d
Days
Class 2
Risk

K851153 is an FDA 510(k) clearance for the COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Astral Medical Systems (Buena Park, US). The FDA issued a Cleared decision on November 5, 1985 after a review of 228 days - an extended review cycle.

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 Astral Medical Systems devices

Submission Details

510(k) Number K851153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1985
Decision Date November 05, 1985
Days to Decision 228 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 113d · This submission: 228d
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 119
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K851153.
MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP
K860342 · Bio/Data Corp. · Mar 1986
MICROSAMPLE COAGULATION ANALYSER MODEL 110P
K854546 · Bio/Data Corp. · Jan 1986
THROMBOPLASTIN-R REAGENT
K853986 · American Dade · Nov 1985
KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS
K853328 · Ortho Diagnostic Systems, Inc. · Nov 1985
CALCIUM CHLORIDE
K853246 · Bio/Data Corp. · Aug 1985
CITREX I
K853076 · Bio/Data Corp. · Aug 1985