Cleared Traditional

K900506 - MODIFIED COATRON II AND COATRON JR.

K900506 is an FDA 510(k) clearance for MODIFIED COATRON II AND COATRON JR., manufactured by Astral Medical Systems. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K900506 · Astral Medical Systems · Hematology device
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Mar 1990
Decision
38d
Days
Class 2
Risk

K900506 is an FDA 510(k) clearance for the MODIFIED COATRON II AND COATRON JR.. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Astral Medical Systems (Indianapolis, US). The FDA issued a Cleared decision on March 12, 1990 after a review of 38 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Astral Medical Systems devices

FDA 510(k) Submission Details - K900506

510(k) Number K900506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1990
Decision Date March 12, 1990
Days to Decision 38 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 113d · This submission: 38d
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 160
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K900506.
HEPARIN ADSORBENT
K912061 · Sigma Diagnostics, Inc. · Jul 1991
ACS 0.02 M CALCIUM CHLORIDE
K902458 · Analytical Control Systems, Inc. · Aug 1990
COAG-A-MATE - RA4
K900917 · Organon Teknika Corp. · Apr 1990
COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN
K900377 · Baxter Healthcare Corp · Mar 1990
PLATELET AGGREGATION PROFILER MODEL PAP-4C
K893650 · Bio/Data Corp. · Jun 1989
PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER
K884534 · Pall Biomedical Products Co. · Jan 1989