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

DXK — Predicate Candidate Screening

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

94 daysmedian FDA review time

207 days90th percentile

78clearances measured

K-number	Device	Applicant	Decided	Review days
K181042	Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter	Boston Scientific Corporation	2018-05-17	28
K160173	Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra	Boston Scientific Corporation	2016-02-26	30
K031148	IN-VISION IMAGING SYSTEM	Jomed, Inc.	2003-05-28	48
K934887	9750 ATHENA ETHERNET OPTION	S & W Medico Teknik A/S	1994-01-14	94
K913209	ACCESSORY TO GENESIS III (GCFM)	Biosound, Inc.	1992-05-15	301
K911384	CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600	Endosonics Corp.	1991-06-25	89
K904832	MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST	Hewlett-Packard Co.	1991-04-22	181
K904975	VISTA VIEWING STATION	Prism Imaging, Inc.	1991-02-25	116
K904978	SOFTWARE PROGRAM USED W/PRISM PRODUCTS	Prism Imaging, Inc.	1991-02-25	116
K904976	CINE'VIEW - STRESS ECHO & IMAGE REVIEW	Prism Imaging, Inc.	1991-02-25	116
K904977	CINE/VIEW PLUS - CARDIOLOGY WORKSTATION	Prism Imaging, Inc.	1991-02-25	116
K910029	PATIENT CARE MANAGEMENT SYSTEM MODIFICATION	Spacelabs, Inc.	1991-01-31	28
K903839	INTERSPEC APOGEE	Interspec, Inc.	1990-11-16	87
K903710	WASHINGTON CARDIAC MONITOR	Washington Biolab, Inc.	1990-11-09	87
K901592	MODEL MD-5 DOPPLER	D. E. Hokanson, Inc.	1990-10-22	200
K903414	TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN	Echo Ultrasound	1990-09-19	51
K901657	ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND	Hitachi Medical Corp. of America	1990-09-04	147
K901658	ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND	Hitachi Medical Corp. of America	1990-09-04	147
K900350	LEOCOR CORFLO(TM) PUMP	Leocor, Inc.	1990-07-17	174
K901562	CVIS INSIGHT IMAGING CATHETER	Cardiovascular Imaging Systems, Inc.	1990-07-09	97
K900002	DOPPLER OPTION FOR PLATINUM	Philips Medical Systems North America, Inc.	1990-04-02	90
K895326	EUB-165	Hitachi Medical Corp. of America	1990-03-22	205
K896543	ULTRAMARK 7 ULTRASOUND SYSTEM	Advanced Technology Laboratories, Inc.	1990-02-15	90
K894370	GENESIS III, (MOD. 7003/7004)	Biosound, Inc.	1990-01-29	199
K894632	MODEL SSH-140A ULTRASOUND IMAGING SYSTEM	Toshiba America Medical Systems, In.C	1989-10-19	87
K885349	SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD.	Sonotek Corp.	1989-06-22	176
K883845	RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER	Phoenix Imaging	1989-02-03	144
K883888	CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.	Advanced Biosearch Assn.	1988-12-12	88
K880217	SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.	Ge Medical Systems Information Technologies	1988-04-25	96
K870878	EUB-305 DIAGNOSTIC ULTRASOUND DEVICE	Hitachi Medical Corp. of America	1988-04-22	415
K871555	RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.	General Electric Co.	1988-03-02	315
K875272	SONOLINE CF	Siemens Medical Laboratories, Inc.	1988-02-18	56
K873032	GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN	Biosound, Inc.	1988-02-18	198
K873762	SERIES 77000 ULTRASOUND IMAGING SYSTEM	Hewlett-Packard Co.	1988-02-18	155
K871697	GENESIS II	Biosound, Inc.	1987-11-06	190
K863387	MULTIPLE	Del Mar Avionics	1987-09-04	366
K871400	SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING	Ge Medical Systems Information Technologies	1987-07-24	107
K863589	MODEL 600 VASCULAR DUPLEX IMAGER	Multigon Industries, Inc.	1987-06-24	282
K862859	EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND	Biosound, Inc.	1987-02-02	188
K864657	ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM	Advanced Technology Laboratories, Inc.	1987-02-02	66
K863965	KENZ-ECG 102	Compumed, Inc.	1986-12-22	73
K861710	MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY	Johnson & Johnson Professionals, Inc.	1986-07-09	65
K855229	CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM	Vingmed, Inc.	1986-03-25	85
K853115	SONOLAYER S, SSH-60A/SDS-60A	Toshiba Medical Systems	1986-03-12	231
K852739	SONOLINE SX ULTRASOUND SCANNER	Siemens Medical Solutions USA, Inc.	1986-03-10	256
K854606	SONOLAYER S, SSH-65A	Toshiba Medical Systems	1986-02-20	94
K853769	IRREGULAR CURVE TRACING REVISITION & DOPPLER	Hewlett-Packard Co.	1985-10-31	52
K851901	750 SD ULTRASOUND SCANNER(MODIFICATION)	Ultrasonix, Inc.	1985-10-23	176
K852543	KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM	Kontron Instruments, Inc.	1985-09-20	98
K851426	ACCUCOM CARDIAC OUTPUT MONITOR	Lawrence Medical Systems, Inc.	1985-07-12	93

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