Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Acuson Computed Sonography — Predicate Candidate Screening

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

94 daysmedian FDA review time

192 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days
K893863	ACUSON L538 TRANSDUCER	Acuson Computed Sonography	1990-05-23	364
K874028	ACUSON S328 TRANSDUCER	Acuson Computed Sonography	1988-06-21	263
K874861	ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.	Acuson Computed Sonography	1988-05-11	166
K874363	ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI.	Acuson Computed Sonography	1988-05-02	192
K874922	ACUSON TRANSPERINEAL NEEDLE GUIDE	Acuson Computed Sonography	1988-02-19	78
K874860	ACUSON I7505 TRANSDUCER FOR INTRACAVITARY APPLICA.	Acuson Computed Sonography	1988-02-17	82
K871416	AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER	Acuson Computed Sonography	1987-09-28	174
K871506	ACUSON L538 TRANSDUCER	Acuson Computed Sonography	1987-09-28	164
K871239	ACUSON PHYSIOLOGICAL CONTROL MODULE	Acuson Computed Sonography	1987-06-05	70
K864578	ACUSON TV519 TRANSDUCER	Acuson Computed Sonography	1987-03-27	127
K863236	ACUSON S519B TRANSDUCER	Acuson Computed Sonography	1987-02-13	176
K861579	ACUSON L558 TRANSDUCER	Acuson Computed Sonography	1986-07-30	93
K861596	ACUSON S519 TRANSDUCER	Acuson Computed Sonography	1986-07-30	92
K862159	ACUSON S319 TRANSDUCER	Acuson Computed Sonography	1986-07-24	48
K861866	ACUSON L382 AND L312 TRANSDUCERS	Acuson Computed Sonography	1986-07-18	66
K861577	ACUSON S228, S519 & L558 TRANSDUCERS	Acuson Computed Sonography	1986-06-19	52
K861578	ACUSON S328, L382, L538 & L312 TRANSDUCERS	Acuson Computed Sonography	1986-06-17	50
K854787	ACUSON L538 TRANSDUCER	Acuson Computed Sonography	1986-03-03	94
K853966	ACUSON L312 TRANSDUCER	Acuson Computed Sonography	1986-02-20	147
K854429	ACUSON NEEDLE GUIDE SYSTEM	Acuson Computed Sonography	1986-02-07	94
K854786	ACUSON BL538 TRANSDUCER	Acuson Computed Sonography	1986-01-15	47
K854788	ACUSON AL538 TRANSDUCER	Acuson Computed Sonography	1986-01-15	47
K854785	ACUSON AL558 TRANSDUCER	Acuson Computed Sonography	1986-01-15	47
K852974	ACUSON RADIOLOGY DOPPLER ACCESSORY	Acuson Computed Sonography	1985-10-24	101

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