Cleared Traditional

K854686 - TE-25 COAGURO METER

K854686 is the FDA 510(k) clearance for TE-25 COAGURO METER by Future Impex Corp.. It is a Class 2 Hematology device (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

Submission Details

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.

Device Classification

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

Devices cleared under the same product code (JBP) and FDA review panel - the closest regulatory comparables to K854686.
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
K020914 · Helena Laboratories · May 2002
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
K013078 · Helena Laboratories · Jan 2002
ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
K992851 · Roche Diagnostics Corp. · Jan 2000