Atlas FDA

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

B-K Medical A/S — Predicate Candidate Screening

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

25 daysmedian FDA review time
131 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K043554ULTRASOUND SCANNER MINI FOCUS, MODEL 1402B-K Medical A/S2005-01-14180
K043524ULTRASOUND SCANNER PRO FOCUS, MODEL 2202B-K Medical A/S2005-01-13241
K024236ULTRASOUND SCANNER, TYPE 2400B-K Medical A/S2003-01-17252
K023457ULTRASOUND SCANNER, TYPE 1101B-K Medical A/S2002-11-01170
K011417ULTRASOUND SCANNER, TYPE 2102B-K Medical A/S2001-06-08300
K003986ULTRASOUND SCANNER TYPE 2102B-K Medical A/S2001-04-03980
K003041ULTRASOUND SCANNER TYPE 2101B-K Medical A/S2001-02-071310
K002085ULTRASOUND SCANNER, TYPE 1101B & K Medical A/S2000-08-01220
K000567ULTRASOUND SCANNER TYPE 2102B & K Medical A/S2000-03-09161
K991937ULTRASOUND SCANNER, MODEL TYPE 2101B & K Medical A/S1999-07-30511
K936024ULTRASOUND SCANNER 2001B & K Medical A/S1995-08-226130

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