Cleared Traditional

K862537 - KOAGULAB* M COAGULATION SYSTEM (FDA 510(k) Clearance)

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

K862537 · Ortho Diagnostic Systems, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1986
Decision
19d
Days
Class 2
Risk

K862537 is an FDA 510(k) clearance for the KOAGULAB* M COAGULATION SYSTEM. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on July 21, 1986 after a review of 19 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 Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K862537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1986
Decision Date July 21, 1986
Days to Decision 19 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 113d · This submission: 19d
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 180
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K862537.
STA Satellite Max®
K253658 · Diagnostica Stago, Inc. · Apr 2026
Automated Blood Coagulation Analyzer CN-Series (CN-6000)
K250965 · Sysmex America, Inc. · Jun 2025
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
K251024 · Haemonetics · Apr 2025
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
K243858 · Haemonetics Corporation · Jan 2025
Citrated: K, KH, RTH, FFH
K232018 · Haemonetics Corporation · Mar 2024
ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM
K221359 · Instrumentation Laboratory CO · Sep 2023