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

HGL — Predicate Candidate Screening

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

94 daysmedian FDA review time

207 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days
K952031	ULTRASOUND TRANSDUCER, MODEL US917	Advanced Medical Systems, Inc.	1995-07-18	78
K923335	ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION	Advanced Medical Systems, Inc.	1994-07-22	774
K924516	OP3/VP4	Huntleigh Technology, Inc.	1993-06-28	297
K903348	ULTRASONIC PULSED DOPPLER IMAGING SYSTEM	Advanced Technology Laboratories, Inc.	1990-10-22	88
K900966	EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE	Hitachi Medical Corp. of America	1990-09-12	195
K903316	ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER	Ge Medical Systems Information Technologies	1990-08-22	28
K901142	MER MULTIPLANE VAGINAL PROBE (MVP)	Medical Equipment Resources	1990-08-22	163
K900838	TRANSVAGINAL TRANSDUCER ASSEMBLY	Pie Medical Equipment B.V.	1990-05-23	90
K895449	ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM	Ge Medical Systems Information Technologies	1990-03-05	194
K881263	MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER	Multigon Industries, Inc.	1990-01-05	652
K895647	5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER	Advanced Technology Laboratories, Inc.	1989-12-18	89
K895123	5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER	Advanced Technology Laboratories, Inc.	1989-11-13	90
K895026	HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER	Hewlett-Packard Co.	1989-11-06	90
K894415	DYMAX ENDOVAGINAL BIOPSY GUIDE	Dymax Corp	1989-10-25	100
K892070	GENERAL IVT NEEDLE GUIDE KIT, STERILE	Amedic USA	1989-09-05	158
K881405	SIEMENS INTRAVAGINAL TRANSDUCER	Siemens Medical Solutions USA, Inc.	1988-08-02	120
K875334	KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM	Kontron Instruments, Inc.	1988-03-24	85
K875371	KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM	Kontron Instruments, Inc.	1988-03-24	84
K872265	ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.	Labsonics, Inc.	1988-01-04	207
K871856	ANNULAR ARRAY SCANHEAD	Advanced Technology Laboratories, Inc.	1987-08-28	108
K864219	TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE	Amedic USA	1987-03-27	150
K864908	DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE	Diasonics, Inc.	1987-03-27	102
K864151	280SL IMAGING SYSTEM TRANVAGINAL PROBES	Ge Medical Systems Information Technologies	1987-03-27	155
K863797	BIOPSY NEEDLE GUIDE ATTACHMENT	Elscint, Inc.	1987-03-27	179
K864578	ACUSON TV519 TRANSDUCER	Acuson Computed Sonography	1987-03-27	127
K870709	7.5 MHZ ENDOVAGINAL PROBE	Philips Ultrasound, Inc.	1987-03-27	35
K861371	TRANSVAGINAL PROBE, MODEL ED65M-TV	Elscint, Inc.	1986-07-14	94
K862072	FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01	International Biomedics, Inc.	1986-07-09	40
K861577	ACUSON S228, S519 & L558 TRANSDUCERS	Acuson Computed Sonography	1986-06-19	52
K861578	ACUSON S328, L382, L538 & L312 TRANSDUCERS	Acuson Computed Sonography	1986-06-17	50
K860234	TRANSVAGINAL TRANSDUCER, 5MHZ	Philips Medical Systems, Inc.	1986-05-23	121
K860621	1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507	Impex Medical Systems, Inc.	1986-05-20	90
K860313	3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031	Johnson & Johnson Professionals, Inc.	1986-03-17	48
K827885	BIO-DERM COUPLING LOTION	Whs Products, Inc.	1982-01-29	28
K771869	DIAG. ULTRASOUND B-SCANNER	Accusonics, Inc.	1977-11-02	30
K771151	ARTIUS SYSTEM	General Electric Co.	1977-08-04	41

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