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

Sonicaid, Inc. — Predicate Candidate Screening

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

69 daysmedian FDA review time

168 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K873673	BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL	Sonicaid, Inc.	1988-02-26	168
K872074	5 MHZ TRANSDUCER	Sonicaid, Inc.	1987-08-25	88
K863803	VASOPULSE(TM)/MODEL 5000	Sonicaid, Inc.	1987-05-06	219
K862720	VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES	Sonicaid, Inc.	1986-11-17	123
K861237	VASOVIEW DUPLEX IMAGING SYSTEM	Sonicaid, Inc.	1986-07-14	103
K851102	VASOSCREEN IMPEDANCE PLETHYSMOGRAPH	Sonicaid, Inc.	1985-05-16	58
K833902	VASOSCAN	Sonicaid, Inc.	1984-01-27	74
K832374	PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH	Sonicaid, Inc.	1983-12-01	136
K833488	SONICOMP	Sonicaid, Inc.	1983-11-28	52
K833227	SONICAID MODEL D206E AIR EMBOLI-DETECT	Sonicaid, Inc.	1983-10-27	72
K831371	MODEL FM5	Sonicaid, Inc.	1983-06-30	64
K812256	MODEL AP 180 MINI-MONITOR	Sonicaid, Inc.	1981-10-20	69
K803246	ULTRASONIC STETHOSCOPE	Sonicaid, Inc.	1981-01-28	36
K800858	FETAL HEART DETECTOR #'S D102 & D102R	Sonicaid, Inc.	1980-05-14	29
K800859	FETAL HEART DETECTOR #D206	Sonicaid, Inc.	1980-05-14	29
K790678	INTRAUTERINE CATHETER TIP	Sonicaid, Inc.	1979-05-11	32
K780487	FETAL MONITORING SYSTEM	Sonicaid, Inc.	1978-05-09	43
K771379	FETAL MONITORING SYS. MODEL FM3R	Sonicaid, Inc.	1977-08-03	8

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