Cleared Traditional

K854377 - HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS

K854377 is an FDA 510(k) clearance for HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS, manufactured by Hemotec, Inc.. The device is a Class 2 Hematology device with product code JOX cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K854377 · Hemotec, Inc. · Hematology device
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Dec 1985
Decision
35d
Days
Class 2
Risk

K854377 is an FDA 510(k) clearance for the HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS. Classified as Analyzer, Heparin, Automated (product code JOX), Class II - Special Controls.

Submitted by Hemotec, Inc. (Attleboro, US). The FDA issued a Cleared decision on December 4, 1985 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5680 - 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.

FDA 510(k) Submission Details - K854377

510(k) Number K854377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1985
Decision Date December 04, 1985
Days to Decision 35 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 113d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOX Device Classification - Class 2, Special Controls

Product Code JOX Analyzer, Heparin, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5680
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 - JOX Analyzer, Heparin, Automated

All 14
Devices cleared under the same product code (JOX) and FDA review panel - the closest regulatory comparables to K854377.
HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL
K922031 · Medtronic Hemotec, Inc. · Jul 1992
HEPCON HMS WITH BODY SURFACE AREA CALCULATION
K911240 · Hemotech, Inc. · Jul 1991
HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.
K894317 · Hemotec, Inc. · Sep 1989
HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM
K841021 · Hemotec, Inc. · May 1984
HEPCOL SYSTEM B-10 & B-10-P
K830665 · Hemotec, Inc. · Jun 1983
HEPAQUANT
K813011 · Streck Laboratories, Inc. · Jan 1982
K854377 · HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS
Download PDF Hemotec, Inc.