Cleared Traditional

HEMOTEC HEPCON/SYSTEM FOUR & FOUR P (K820410) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K820410 · Hemotec, Inc. · Hematology device
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Apr 1982
Decision
56d
Days
Class 2
Risk

K820410 is an FDA 510(k) clearance for the HEMOTEC HEPCON/SYSTEM FOUR & FOUR P. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Hemotec, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 9, 1982 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 870.5100 - 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.

View all Hemotec, Inc. devices

Submission Details

510(k) Number K820410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1982
Decision Date April 09, 1982
Days to Decision 56 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 113d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5100
Definition A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End.
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 - LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

All 85
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K820410.
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