Cleared Traditional

K922031 - HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL

K922031 is an FDA 510(k) clearance for HMS PURPLE AND BLACK HEPARIN CARTRIDGES..., manufactured by Medtronic Hemotec, Inc.. The device is a Class 2 Hematology device with product code JOX cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K922031 · Medtronic Hemotec, Inc. · Hematology device
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Jul 1992
Decision
81d
Days
Class 2
Risk

K922031 is an FDA 510(k) clearance for the HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL. Classified as Analyzer, Heparin, Automated (product code JOX), Class II - Special Controls.

Submitted by Medtronic Hemotec, Inc. (Englewood, US). The FDA issued a Cleared decision on July 21, 1992 after a review of 81 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.

View all Medtronic Hemotec, Inc. devices

FDA 510(k) Submission Details - K922031

510(k) Number K922031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1992
Decision Date July 21, 1992
Days to Decision 81 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 113d · This submission: 81d
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 8
Devices cleared under the same product code (JOX) and FDA review panel - the closest regulatory comparables to K922031.
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
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RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
K993519 · Cardiovascular Diagnostics, Inc. · Jan 2000
HEPAQUANT
K813011 · Streck Laboratories, Inc. · Jan 1982