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

Biosound, Inc. — Predicate Candidate Screening

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

190 daysmedian FDA review time

301 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days
K971700	BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER	Biosound, Inc.	1997-07-09	62
K963936	ACCESSPOINT, MED E-MAIL, DICOM READER	Biosound, Inc.	1997-03-31	181
K963262	ARTOSCAN M	Biosound, Inc.	1997-03-28	220
K963662	GALILEO EVOKED POTENTIALRE	Biosound, Inc.	1997-02-26	166
K953716	INTRACAVITY TRANSDUCERS	Biosound, Inc.	1996-04-17	252
K953530	DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A	Biosound, Inc.	1996-04-08	256
K953759	DIAGNOSTIC ULTRASOUND TRANSDUCER	Biosound, Inc.	1996-03-01	203
K953819	DIAGNOSTIC ULTRASOUND TRANDUCER	Biosound, Inc.	1996-03-01	199
K955458	ULTRASOUND PROBE BIOPSY ACCESSORIES	Biosound, Inc.	1996-02-12	75
K953579	TEE PROBE	Biosound, Inc.	1996-02-02	185
K953430	ULTRASOUND PROBE BIOPSY ACCESSORIES	Biosound, Inc.	1995-10-24	95
K941935	LP-12 LAPAROSCOPIC PROBE	Biosound, Inc.	1995-09-18	516
K944287	7050 ULTRASOUND IMAGING SYSTEM	Biosound, Inc.	1995-06-02	273
K944485	4000 AU ULTRASOUND IMAGING SYSTEM	Biosound, Inc.	1995-05-24	253
K934050	TOPOGRAPHIC BRAIN MAPPING OPTION	Biosound, Inc.	1994-02-03	168
K931022	ARTOSCAN	Biosound, Inc.	1993-10-07	220
K922703	THE ACTA FORMULA	Biosound, Inc.	1993-04-27	326
K923894	YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH	Biosound, Inc.	1993-03-10	218
K922488	PHASIS ELECTROMYOGRAPH	Biosound, Inc.	1993-03-02	279
K923860	THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR	Biosound, Inc.	1993-02-04	188
K923950	THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH	Biosound, Inc.	1993-01-26	174
K922291	PERSONAL 120/210 LAPTOP STRESS OPTION	Biosound, Inc.	1992-11-04	173
K915860	LINEAR PERIPHERALVASCULAR ULTRSOUND PROBE	Biosound, Inc.	1992-07-02	185
K913209	ACCESSORY TO GENESIS III (GCFM)	Biosound, Inc.	1992-05-15	301
K914006	BIPLANE TRANSRECTAL PROBE	Biosound, Inc.	1992-04-02	206
K920364	ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS	Biosound, Inc.	1992-03-17	49
K912088	BIOPSY ACCESSORIES FOR ULTRASOUND PROBES	Biosound, Inc.	1991-12-05	206
K895645	BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM	Biosound, Inc.	1990-03-06	167
K894370	GENESIS III, (MOD. 7003/7004)	Biosound, Inc.	1990-01-29	199
K894163	PHASE 2 TRANSCRANIAL PROBE	Biosound, Inc.	1989-09-12	90
K883238	GENESIS II TRANSCRANIAL PROBE	Biosound, Inc.	1988-08-24	23
K881723	GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER	Biosound, Inc.	1988-08-12	113
K871442	BIOSOUND MMI ULTRASOUND	Biosound, Inc.	1988-05-20	403
K873032	GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN	Biosound, Inc.	1988-02-18	198
K870899	EZU-PC 2A/5.0 & 3A/3.5MHZ, EUP-CD 121/5.0 CONVEX	Biosound, Inc.	1987-12-30	300
K871697	GENESIS II	Biosound, Inc.	1987-11-06	190
K862859	EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND	Biosound, Inc.	1987-02-02	188
K862841	HIGH VELOCITY CW DOPPLER SYSTEM	Biosound, Inc.	1986-11-10	104
K837063	BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEM	Biosound, Inc.	1983-04-04	77

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