Cleared Traditional

K841021 - HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM

K841021 is an FDA 510(k) clearance for HEMOTEC, 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 74-day FDA review.

K841021 · Hemotec, Inc. · Hematology device

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May 1984

Decision

74d

Days

Class 2

Risk

K841021 is an FDA 510(k) clearance for the HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM. Classified as Analyzer, Heparin, Automated (product code JOX), Class II - Special Controls.

Submitted by Hemotec, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1984 after a review of 74 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 - K841021

510(k) Number	K841021 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 12, 1984
Decision Date	May 25, 1984
Days to Decision	74 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

39d faster than avg

Panel avg: 113d · This submission: 74d

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 K841021.

HEPCON HMS WITH BODY SURFACE AREA CALCULATION

K911240 · Hemotech, Inc. · Jul 1991

HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.

K894317 · Hemotec, Inc. · Sep 1989

HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS

K854377 · Hemotec, Inc. · Dec 1985

HEPCOL SYSTEM B-10 & B-10-P

K830665 · Hemotec, Inc. · Jun 1983

HEPAQUANT

K813011 · Streck Laboratories, Inc. · Jan 1982

HEPCON/SYSTEM RC-10

K800161 · Hemotec, Inc. · Mar 1980

FDA 510(k) Resources - Hematology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K841021

Hemotec, Inc.

Mchenry, IL · US

Regulatory profile

15 submissions 15 cleared

100% clearance rate · Active in Hematology

View all devices by Hemotec, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: May 25, 1984. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: November 2026.

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