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

Sonoscape Medical Corp. — Predicate Candidate Screening

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

100 daysmedian FDA review time

253 days90th percentile

25clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K254028	Digital Color Doppler Ultrasound System (Autra RS, Autra 90,	Sonoscape Medical Corp.	2026-05-15	150	0
K252498	Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X	Sonoscape Medical Corp.	2025-12-05	119	0
K241949	Digital Color Doppler Ultrasound System (P60 Series)	Sonoscape Medical Corp.	2025-01-17	198	0
K231813	Ultrasonic Gastrovideoscope	Sonoscape Medical Corp.	2024-03-08	261	0
K222596	S90 Exp Series Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	2023-02-10	168	0
K221089	P12 Elite Series Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	2022-09-15	155	0
K221140	P20 Elite Series Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	2022-09-13	147	0
K222020	HD-550 Video Endoscope System	Sonoscape Medical Corp.	2022-09-08	62	0
K211882	HD-550 Video Endoscope System	Sonoscape Medical Corp.	2022-04-01	284	0
K201059	S60 Elite Series/S70 Series Digital Color Doppler Ultrasound	Sonoscape Medical Corp.	2020-07-30	100	0
K182648	X5 Series Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	2019-01-29	127	0
K173921	HD-500 Video Endoscope System	Sonoscape Medical Corp.	2018-09-05	253	0
K172993	P20 Series Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	2017-12-05	69	0
K173058	P10 Series Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	2017-12-01	64	0
K172082	S60 Series Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	2017-09-21	73	0
K170999	P50 Series Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	2017-07-12	100	0
K171000	P60 Series Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	2017-07-11	99	0
K170303	E5 Series Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	2017-05-19	108	0
K163427	X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound	Sonoscape Medical Corp.	2017-01-03	28	0
K160283	S45 Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	2016-04-04	61	0
K160258	X5 Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	2016-04-01	60	0
K152854	S50 Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	2016-01-13	106	0
K152396	S12 Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	2015-09-03	10	0
K152164	S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound Syst	Sonoscape Medical Corp.	2015-08-28	25	0
K152165	S9 Portable Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	2015-08-26	23	2

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