Cleared Traditional

K854686 - TE-25 COAGURO METER

K854686 is an FDA 510(k) clearance for TE-25 COAGURO METER, manufactured by Future Impex Corp.. The device is a Class 2 Hematology device with product code JBP cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K854686 · Future Impex Corp. · Hematology device
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Jun 1986
Decision
196d
Days
Class 2
Risk

K854686 is an FDA 510(k) clearance for the TE-25 COAGURO METER. Classified as Activated Whole Blood Clotting Time (product code JBP), Class II - Special Controls.

Submitted by Future Impex Corp. (Deerpark, US). The FDA issued a Cleared decision on June 4, 1986 after a review of 196 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7140 - 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 Future Impex Corp. devices

FDA 510(k) Submission Details - K854686

510(k) Number K854686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1985
Decision Date June 04, 1986
Days to Decision 196 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 113d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JBP Device Classification - Class 2, Special Controls

Product Code JBP Activated Whole Blood Clotting Time
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7140
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 - JBP Activated Whole Blood Clotting Time

All 16
Devices cleared under the same product code (JBP) and FDA review panel - the closest regulatory comparables to K854686.
HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
K960749 · International Technidyne Corp. · Aug 1996
CATALOG NO. J-ACT+ & QC-ACT+
K941007 · International Technidyne Corp. · Jun 1994
HEMOCHRON(R) KACT
K913861 · International Technidyne Corp. · Oct 1991
HEMOCHRON THROMBOCHRONOMETER
K832189 · International Technidyne Corp. · Oct 1983
ACTIVATOR
K790346 · Tri-Med, Inc. · Mar 1979