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

Acuson Corp. — Predicate Candidate Screening

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

175 daysmedian FDA review time

415 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K023772	KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM	Acuson Corp.	2002-11-22	10	4
K022896	CSV12 SOFTWARE VIEWER	Acuson Corp.	2002-10-03	30	0
K022567	SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM	Acuson Corp.	2002-08-13	11	0
K021497	CYPRESS ULTRASOUND SYSTEM	Acuson Corp.	2002-07-09	61	2
K010950	CYPRESS SYSTEM	Acuson Corp.	2001-06-27	90	0
K002807	3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING	Acuson Corp.	2000-12-01	84	0
K992631	ACUNAV DIAGNOSTIC ULTRASOUND CATHETER	Acuson Corp.	1999-12-15	131	1
K992580	FETAL ASSESSMENT CAP	Acuson Corp.	1999-10-18	77	0
K991805	ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION	Acuson Corp.	1999-08-02	68	1
K973767	HARMONIC IMAGING WITH CONTRAST	Acuson Corp.	1997-12-23	82	0
K973079	L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM	Acuson Corp.	1997-11-05	79	0
K942296	V5M	Acuson Corp.	1995-03-02	294	0
K935595	ACUSON MODEL 3001	Acuson Corp.	1995-03-02	468	0
K930964	ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)	Acuson Corp.	1994-10-26	609	0
K934915	ACUSON MODEL 2001	Acuson Corp.	1994-10-21	371	0
K940285	ACUSON PICTURE ARCHIVING & COMMUNICATION SYSTEM MODIFICATION	Acuson Corp.	1994-04-29	109	0
K933663	MODIFICATION OF ACUSON V510B TRANSDUCER	Acuson Corp.	1994-01-21	177	0
K920882	ACUSON V714 TRANSDUCER	Acuson Corp.	1993-03-26	394	0
K921341	ACUSON V714OR TRANSDUCER	Acuson Corp.	1992-11-27	252	0
K902515	ACUSON S228 TRANSDUCER FOR TRANSCRANIAL COLOR DOPP	Acuson Corp.	1992-09-04	822	0
K921670	ACUSON IMAGE MANAGEMENT SYSTEM	Acuson Corp.	1992-06-25	78	0
K911916	ACUSON C366 TRANSDUCER	Acuson Corp.	1992-06-18	415	0
K911767	ACUSON V510 TRANSDUCER	Acuson Corp.	1991-10-31	195	0
K904600	L582 TRANSDUCER	Acuson Corp.	1991-06-24	257	0
K905456	L328 TRANSDUCER	Acuson Corp.	1991-05-28	175	0
K904951	S5192R TRANSDUCER	Acuson Corp.	1991-04-29	178	0
K904459	C544 TRANSDUCER	Acuson Corp.	1991-03-29	179	0
K903561	QUICK-CLIP NEEDLE GUIDE	Acuson Corp.	1991-03-05	210	0
K900560	ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE	Acuson Corp.	1990-12-03	299	0
K897151	ACUSON V328 AND C5432 TRANSDUCERS	Acuson Corp.	1990-07-03	189	0
K890275	ACUSON S328 TRANSDUCER FOR FETAL CARDIAC PULSED	Acuson Corp.	1989-07-31	194	0
K884271	ACUSON S328 TRANSDUCER FOR FETAL PULSED DOPPLER	Acuson Corp.	1989-07-27	289	0
K890055	ACUSON S228 TRANSDUCER FOR TRANSCRANIAL DOPPLER	Acuson Corp.	1989-05-16	130	0
K884632	ACUSON I5100 ULTRASOUND TRANSDUCER	Acuson Corp.	1989-01-13	67	2
K883752	ACUSON L538 TRANSDUCER	Acuson Corp.	1988-12-01	90	0
K882737	ACUSON I7505 TRANSDUCER, ULTRASOUND TRANSDUCER	Acuson Corp.	1988-09-08	69	0
K882549	ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.	Acuson Corp.	1988-07-21	31	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