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

Kt Medical, Inc. · Predicate Candidate Screening

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

28 daysmedian FDA review time

109 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K800653	SINVISION LINEAR ARRAY REAL TIME	Kt Medical, Inc.	1980-07-21	119
K800652	MODEL E03 ECHO-OPTHALMOSCOPE	Kt Medical, Inc.	1980-05-14	51
K800101	4200 ME ECHOENCEPHALOGRAPH	Kt Medical, Inc.	1980-05-02	109
K800092	COMBISON COMPUTER	Kt Medical, Inc.	1980-04-08	85
K800099	INTRACULA II	Kt Medical, Inc.	1980-02-21	38
K800100	7200 MA ECHO-OPHTHALMOSCOPE	Kt Medical, Inc.	1980-02-21	38
K800091	COMBISON 100-MODEL 100 & 110	Kt Medical, Inc.	1980-02-11	28
K800098	MINIFETON 200	Kt Medical, Inc.	1980-02-11	28
K800094	COMBISON 200 & COMBISON 202	Kt Medical, Inc.	1980-02-11	28
K800096	AMBIVASON DR-200	Kt Medical, Inc.	1980-02-11	28
K800093	TRANSDUCER	Kt Medical, Inc.	1980-02-11	28
K800095	MGD-3	Kt Medical, Inc.	1980-02-11	28
K800097	MINIVASON 9	Kt Medical, Inc.	1980-02-11	28

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