Cleared Traditional

HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High (K192842) - FDA 510(k) Clearance

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

K192842 · Eurotrol B.V. · Hematology device
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Nov 2019
Decision
43d
Days
Class 2
Risk

K192842 is an FDA 510(k) clearance for the HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High. Classified as Control, Hemoglobin (product code GGM), Class II - Special Controls.

Submitted by Eurotrol B.V. (Ede, NL). The FDA issued a Cleared decision on November 15, 2019 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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 Eurotrol B.V. devices

Submission Details

510(k) Number K192842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2019
Decision Date November 15, 2019
Days to Decision 43 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 113d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGM Control, Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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.