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

MAA — Predicate Candidate Screening

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

199 daysmedian FDA review time

497 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K102138	ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER	Edan Instruments, Inc.	2010-10-28	90
K090499	LIFEDOP MODEL, L350R	Summit Doppler Systems, Inc.	2009-03-31	34
K915138	GE SONOCHROME	GE Medical Systems	1992-10-20	342
K905536	FETAL DOPPLER	Toshiba America Medical Systems, In.C	1992-04-21	497
K904600	L582 TRANSDUCER	Acuson Corp.	1991-06-24	257
K905456	L328 TRANSDUCER	Acuson Corp.	1991-05-28	175
K904951	S5192R TRANSDUCER	Acuson Corp.	1991-04-29	178
K895909	SONICAID MODEL VASOFLO 4	Oxford Medilog, Inc.	1990-07-09	272
K894992	QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM	Quantum Medical Systems, Inc.	1990-02-23	199

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