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

HEM — Predicate Candidate Screening

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

81 daysmedian FDA review time

189 days90th percentile

30clearances measured

K-number	Device	Applicant	Decided	Review days
K951393	ABACUS OB ULTRASOUNG COMPUTER SOFTWARE	Solomon Technology Labs	1995-05-01	35
K942490	BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND	Medical Soft, Inc.	1995-02-15	266
K910426	SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT	Shimadzu Medical Systems	1991-06-06	127
K905000	ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER	Corometrics Medical Systems, Inc.	1991-01-31	85
K900505	SONOACE 88 PORTABLE ULTRASOUND SCANNER	Medison Co., Ltd.	1990-08-10	189
K900271	MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK	Digisonics, Inc.	1990-04-19	90
K890637	EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE	Elscint, Inc.	1989-06-12	124
K881329	FETAL DOPPLER FOR ULTRAMARK 4 AND 8	Advanced Technology Laboratories, Inc.	1989-04-14	380
K885061	SIEMENS INTRAVAGINAL TRANSDUCER	Siemens Medical Solutions USA, Inc.	1989-02-23	79
K880900	SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER	Corometrics Medical Systems, Inc.	1988-06-01	91
K881185	ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.	Philips Medical Systems (Cleveland), Inc.	1988-06-01	72
K862364	NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)	Swemed Laboratories, Inc.	1986-08-19	56
K862627	SONORANGER TRANSVAGINAL PROBE	Ausonics Pty , Ltd.	1986-08-01	22
K861931	645OB SECTOR/LINEAR ULTRASOUND SCANNER	Ge Medical Systems Information Technologies	1986-07-31	72
K860233	5 MHZ INTRACAVITARY PROBE, MODEL H4222V	General Electric Co.	1986-06-02	131
K853711	5.0 MHZ INTRACAVITARY SECTOR PROBE	General Electric Co.	1985-12-18	104
K851902	MODEL U-1000 ULTRASONIC SCANNER	Fukuda Denshi USA, Inc.	1985-09-27	150
K853407	INTRA VAGINAL TRANSDUCER	Advanced Technology Laboratories, Inc.	1985-09-27	46
K852439	FETA SCAN 1000 OBSTETRICAL IMAGER	International Biomedics, Inc.	1985-08-30	81
K842261	OB ULTRASOUND LINEAR SCANNER 630	Ge Medical Systems Information Technologies	1984-09-19	104
K840623	OBSTETRICAL ULTRASOUND COMPUTER	R & S Systems	1984-05-11	87
K834088	GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING	Whs Products, Inc.	1983-12-15	92
K833488	SONICOMP	Sonicaid, Inc.	1983-11-28	52
K811520	GRAYLINE IMAGING SYSTEM	Sonics Research Corp.	1981-07-02	34
K810305	DATASON DB ULTRASOUND IMAGING SYSTEM	General Electric Co.	1981-03-13	36
K780876	ULTRASONIC IMAGER	Air-Shields, Inc.	1978-06-27	28
K771816	ROCHE AXISCAN 5	Roche Medical Electronics, Inc.	1977-10-19	22
K770644	ULTRASOUND B-SCANNING SYSTEM	Unirad Corp.	1977-04-14	10
K760874	V.I. OCTOSON ULTRASONIC SYSTEM	General Electric Co.	1976-12-16	59
K761052	REAL TIME OBSTETRICAL ULTRASONIC SCANNER	Smithkline Diagnostics, Inc.	1976-12-16	31

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