Atlas FDA

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

B-K Medical Aps — Predicate Candidate Screening

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

118 daysmedian FDA review time
168 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K140428ULTRASOUND SCANNER SYSTEM BK2300B-K Medical Aps2014-05-301000
K132335ULTRASOUND SCANNER FLEX FOCUS 1202B-K Medical Aps2014-01-101681
K132346ULTRASOUND SCANNER PRO FOCUS 2202B-K Medical Aps2014-01-101650
K132677ULTRASOUND SCANNER FLEX FOCUS 1202B-K Medical Aps2014-01-071320
K132685ULTRASOUND SCANNER PRO FOCUS 2202B-K Medical Aps2014-01-061310
K123254ULTRASOUND SCANNER FLEX FOCUSB-K Medical Aps2013-02-131180
K100919PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202B-K Medical Aps2011-12-166230
K083667NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, B-K Medical Aps2009-02-02530
K081323BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPB-K Medical Aps2008-07-22710
K081154ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202B-K Medical Aps2008-05-23300
K070077ULTRASOUND SCANNER PROFOCUS, MODEL 2202B-K Medical Aps2007-03-05560

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