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

Bk Medical Aps — Predicate Candidate Screening

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

95 daysmedian FDA review time

132 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K231764	Ultrasound System 1300	Bk Medical Aps	2023-10-23	129	1
K223830	Ultrasound System 2300	Bk Medical Aps	2023-04-11	111	6
K222441	Ultrasound System 2300	Bk Medical Aps	2022-12-07	117	0
K180737	Ultrasound Scanner System bk2300	Bk Medical Aps	2018-08-01	132	0
K173569	Ultrasound System 1300	Bk Medical Aps	2018-02-23	95	0
K161960	bk2300	Bk Medical Aps	2016-10-17	91	0
K151910	Ultrasound Scanner System BK2300	Bk Medical Aps	2015-10-05	84	0
K152052	Ultrasound Scanner System bk2300	Bk Medical Aps	2015-09-16	55	0
K143298	Ultrasound Scanner System bk2300	Bk Medical Aps	2015-01-16	60	0

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