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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Eurotrol B.V. · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

56 daysmedian FDA review time
358 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K192842HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo HighEurotrol B.V.2019-11-15430
K182744HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighEurotrol B.V.2019-02-011260
K152553CueSee HypoxicEurotrol B.V.2016-04-222270
K131595EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVMEurotrol B.V.2013-07-26530
K121467EUROTROL HEMATOCRIT CONTROLEurotrol B.V.2013-05-103580
K121468EUROTROL GAS-ISE METABOLITESEurotrol B.V.2012-06-22360
K060215ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.0Eurotrol B.V.2006-03-24560

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda