Cleared Traditional

K812121 - DIGICLOT 2-#820

K812121 is the FDA 510(k) clearance for DIGICLOT 2-#820 by Volu Sol Medical Industries. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K812121 · Volu Sol Medical Industries · Hematology device
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Nov 1981
Decision
112d
Days
Class 2
Risk

K812121 is an FDA 510(k) clearance for the DIGICLOT 2-#820. 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 16, 1981 after a review of 112 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

Submission Details

510(k) Number K812121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1981
Decision Date November 16, 1981
Days to Decision 112 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
1d faster than avg
Panel avg: 113d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 116
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K812121.
COBAS-FIBRO
K842717 · Roche Diagnostic Systems, Inc. · Oct 1984
THROMBOPLASTIN - FS
K833272 · American Dade · Nov 1983
ORTHO ABNORMAL COAGULATION LEVEL I/II
K832225 · Ortho Diagnostic Systems, Inc. · Aug 1983
MULTI CLOT-#819
K812122 · Volu Sol Medical Industries · Nov 1981
NORM-TROL
K792310 · Helena Laboratories · Dec 1979
ELVI 818 DIGICLOT MULTISCAN
K791586 · Volu Sol Medical Industries · Sep 1979