Cleared Traditional

K812122 - MULTI CLOT-#819

K812122 is an FDA 510(k) clearance for MULTI CLOT-#819, manufactured by Volu Sol Medical Industries. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K812122 · Volu Sol Medical Industries · Hematology device
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Nov 1981
Decision
106d
Days
Class 2
Risk

K812122 is an FDA 510(k) clearance for the MULTI CLOT-#819. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on November 10, 1981 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 Volu Sol Medical Industries devices

FDA 510(k) Submission Details - K812122

510(k) Number K812122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1981
Decision Date November 10, 1981
Days to Decision 106 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
7d faster than avg
Panel avg: 113d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPA Device Classification - Class 2, Special Controls

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 158
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K812122.
THROMBOPLASTIN - FS
K833272 · American Dade · Nov 1983
ORTHO ABNORMAL COAGULATION LEVEL I/II
K832225 · Ortho Diagnostic Systems, Inc. · Aug 1983
DIGICLOT 2-#820
K812121 · Volu Sol Medical Industries · Nov 1981
MLA ELECTRA 700
K812124 · Medical Laboratory Automation Systems, Inc. · Oct 1981
NORM-TROL
K792310 · Helena Laboratories · Dec 1979
ELVI 818 DIGICLOT MULTISCAN
K791586 · Volu Sol Medical Industries · Sep 1979