Cleared Traditional

K940401 - JR. MICROCOAGULATION SYSTEM

K940401 is an FDA 510(k) clearance for JR. MICROCOAGULATION SYSTEM, manufactured by International Technidyne Corp.. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K940401 · International Technidyne Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
104d
Days
Class 2
Risk

K940401 is an FDA 510(k) clearance for the JR. MICROCOAGULATION SYSTEM. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on May 11, 1994 after a review of 104 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 International Technidyne Corp. devices

FDA 510(k) Submission Details - K940401

510(k) Number K940401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1994
Decision Date May 11, 1994
Days to Decision 104 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 113d · This submission: 104d
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 145
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K940401.
TOA MEDICAL ELECTRONICS CA-5000
K942097 · Sysmex Corp. · Mar 1995
HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM
K940957 · International Technidyne Corp. · Oct 1994
ACT CONTROL SET
K940840 · Sigma Diagnostics, Inc. · Jul 1994
TOA MEDICAL ELECTRONICS CA-5000
K933886 · Toa Medical Electronics USA, Inc. · Jan 1994
R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470
K934747 · R & D Batteries, Inc. · Dec 1993
CA-1000 AUTOMATED COAGULATION ANALYZER
K931149 · Toa Medical Electronics USA, Inc. · Nov 1993