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

Aloka Co., Ltd. · Predicate Candidate Screening

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

43 daysmedian FDA review time

202 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K111227	ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM	Aloka Co., Ltd.	2011-05-13	11	0
K110207	ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM	Aloka Co., Ltd.	2011-02-17	23	0
K093488	ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM	Aloka Co., Ltd.	2009-11-20	10	0
K083254	ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM	Aloka Co., Ltd.	2008-12-19	45	0
K081843	ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1	Aloka Co., Ltd.	2008-07-15	15	0
K080176	ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM	Aloka Co., Ltd.	2008-02-29	36	0
K072285	ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM	Aloka Co., Ltd.	2007-08-30	14	0
K060059	ALOKA SD-3500 ULTRASOUND SYSTEM	Aloka Co., Ltd.	2006-01-13	4	0
K043196	ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM	Aloka Co., Ltd.	2004-11-30	12	0
K040719	ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL	Aloka Co., Ltd.	2004-03-26	7	0
K033311	ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM	Aloka Co., Ltd.	2003-10-29	15	0
K023996	ALOKA SSD-3500 ULTRASOUND SYSTEM	Aloka Co., Ltd.	2002-12-18	15	0
K020668	ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003	Aloka Co., Ltd.	2002-07-10	131	0
K012253	SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM	Aloka Co., Ltd.	2001-08-30	43	0
K012080	SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM	Aloka Co., Ltd.	2001-08-29	57	0
K011457	ALOKA SSD-5500 WITH KI AND A-SMA	Aloka Co., Ltd.	2001-05-23	12	0
K011314	OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-55	Aloka Co., Ltd.	2001-05-15	15	2
K011315	SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5	Aloka Co., Ltd.	2001-05-15	15	0
K003739	ALOKA SSD-4000	Aloka Co., Ltd.	2000-12-27	23	0
K002784	ALOKA UST-5280-5	Aloka Co., Ltd.	2000-09-20	14	0
K992663	ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM	Aloka Co., Ltd.	1999-08-24	15	0
K983879	ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM	Aloka Co., Ltd.	1999-03-22	140	0
K974544	ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER	Aloka Co., Ltd.	1998-03-18	104	0
K972465	ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM	Aloka Co., Ltd.	1997-08-15	45	0
K964549	ALOKA UST-5258-5 DIAGNOSTIC ULTRASOUND TRANSDUCER	Aloka Co., Ltd.	1997-06-03	202	0
K963616	ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM	Aloka Co., Ltd.	1997-04-03	205	0
K954022	ALOKA OMNIVIEW DIAGNOSTIC ULTRASOUND SYSTEM	Aloka Co., Ltd.	1996-01-17	142	0
K950607	UST-5268P-5 TRANSDUCER	Aloka Co., Ltd.	1995-09-15	218	0
K943113	SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM	Aloka Co., Ltd.	1995-02-01	219	0
K943637	SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM	Aloka Co., Ltd.	1994-12-29	155	0
K941652	ALOKA SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM MODIFICATION	Aloka Co., Ltd.	1994-10-21	199	0
K925486	UST-5522-7.5 & UST-5522L-7.5 INTRAOPERATIVE TRANS.	Aloka Co., Ltd.	1993-02-12	105	0
K925646	SSD-2000 DIAG. ULTRASOUND SYS.&UST-979-3.5 TRANS.	Aloka Co., Ltd.	1993-02-12	95	0
K923269	CONVEX AND LINEAR ARRAY TRANSDUCERS	Aloka Co., Ltd.	1992-12-03	150	0
K922549	UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35	Aloka Co., Ltd.	1992-09-21	112	0
K837304	MODELS 246 AND 210F LINEAR ARRAY ULTRASOUND SCANNER	Aloka Co., Ltd.	1983-05-09	52	0
K827177	LTRASONIC SCANNER U.S. ALOKA SSD-500	Aloka Co., Ltd.	1982-04-25	65	0
K827284	MODEL SSD-119	Aloka Co., Ltd.	1982-04-21	22	0
K827285	MODEL SSD-710	Aloka Co., Ltd.	1982-04-21	22	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