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

JOP — Predicate Candidate Screening

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

141 daysmedian FDA review time

258 days90th percentile

72clearances measured

K-number	Device	Applicant	Decided	Review days
K242662	Falcon/Xpress (Falcon/Xpress)	Viasonix , Ltd.	2024-12-18	105
K233976	VasoGuard (V10, V8, V6, V4, V2)	Corvascular Diagnostics, LLC	2024-07-19	217
K153762	Smartdop XT6	Koven Technology, Inc.	2016-05-25	147
K131623	SMARTDOP XT	Koven Technology, Inc.	2014-01-17	227
K131860	VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORD	Us Vascular, LLC	2013-09-27	95
K111416	FALCON	Viasonix , Ltd.	2011-07-15	56
K071730	STUDIODOP VICORDER	Skidmore Medical, Limited	2007-12-20	178
K010482	ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MOD	Echocath, Inc.	2001-03-20	28
K002766	NICOLET VASOGUARD	Nicolet Biomedical	2000-11-30	86
K990642	ECHOFLOW DOPPLER BLOOD VELOCITY METER	Echocath, Inc.	1999-09-16	202
K925078	SPECTRADOP	Bennett and Assoc., Inc.	1995-07-17	1013
K934638	REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW	Koven Technology, Inc.	1994-05-13	231
K912409	MODEL HD-207 BIDIRECTIONAL VELOCITY METER	Koven and Assoc., Inc.	1991-12-23	206
K911320	EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE	Applied Biometrics, Inc.	1991-12-18	267
K910281	INTRAVASCULAR IMAGING SYSTEM/MODIFIED	Intertherapy, Inc.	1991-05-13	110
K905157	FLOSCOPE VASCULAR LAB.	Advance Medical Device, Inc.	1991-03-15	119
K905369	UST-2266U-5 CW DOPPLER TRANSDUCER	Ge Medical Systems Information Technologies	1991-02-11	74
K896264	MILLAR MIKRO-TIP DOPPLER CATHETER	Millar Instruments, Inc.	1990-01-24	85
K890636	CARDIAC COMPUTATION SOFTWARE PACKAGE	Elscint, Inc.	1989-08-07	180
K890638	VOLUME COMPUTATION SOFTWARE PACKAGE	Elscint, Inc.	1989-08-07	180
K892944	INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515	Interspec, Inc.	1989-07-19	89
K881979	RESUBMITTAL OF MI 1000C MICROIMAGER	Ausonics Pty , Ltd.	1989-06-12	396
K883889	TRANSESOPHAGEAL ECHO TRANSDUCER	General Electric Co.	1988-11-29	76
K873674	SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER	Shimadzu Corp.	1988-10-07	392
K881723	GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER	Biosound, Inc.	1988-08-12	113
K871442	BIOSOUND MMI ULTRASOUND	Biosound, Inc.	1988-05-20	403
K873989	DOPPLEX ULTRASONIC DOPPLER SYSTEM	Ultramed, Inc.	1988-03-02	154
K870857	ABCOM 1 CARDIAC OUTPUT MONITOR	Applied Biometrics, Inc.	1987-11-16	258
K870726	RT5000 ECHOCARDIOGRAPHY #H4100C/CE	General Electric Co.	1987-10-20	238
K871727	MODIFIED RADIUS - MODEL NUMBER MM 5000	Ultrasonix, Inc.	1987-09-30	155
K871416	AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER	Acuson Computed Sonography	1987-09-28	174
K871506	ACUSON L538 TRANSDUCER	Acuson Computed Sonography	1987-09-28	164
K870850	MOD 482	Hoffrel Instruments, Inc.	1987-09-08	189
K872074	5 MHZ TRANSDUCER	Sonicaid, Inc.	1987-08-25	88
K871212	MASCOT CW DOPPLER SYSTEM	Imex Medical Systems, Inc.	1987-08-14	141
K870607	SSD-725 ULTRASOUND SECTOR SCANNER	Ge Medical Systems Information Technologies	1987-08-10	180
K870150	CONTINUOUS CARDIAC OUTPUT MONITORING SYSTEM	Cardio Metrics, Inc.	1987-08-07	206
K870916	SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS.	Ge Medical Systems Information Technologies	1987-07-21	137
K864980	3MHZ ANNULAR ARRAY	Philips Ultrasound, Inc.	1987-05-11	140
K862913	CARDIOSCAN WITH DOPPLER OPTION	Interspec, Inc.	1986-11-04	95
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
K861737	MERIDIAN IMAGING SYSTEM	Johnson & Johnson Professionals, Inc.	1986-07-24	79
K861866	ACUSON L382 AND L312 TRANSDUCERS	Acuson Computed Sonography	1986-07-18	66
K861378	ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST	Ultramed, Inc.	1986-07-07	84
K860579	CARDIOSCAN DOPPLER OPTION	Interspec, Inc.	1986-06-30	132
K860652	ULTRASOUND TRANSDUCER #21230A 7.5MHZ SHORT FOCUS	Hewlett-Packard Co.	1986-05-08	76
K854996	ULTRASONIC COUPLANT GEL	Johnson & Johnson Professionals, Inc.	1986-04-14	123
K853240	MERIDIAN ULTRASOUND IMAGING SYSTEM	Johnson & Johnson Professionals, Inc.	1986-02-21	204

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