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

Takeda Medical, Inc. · Predicate Candidate Screening

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

154 daysmedian FDA review time

240 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K854797	TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER, UA-731	Takeda Medical, Inc.	1986-05-09	158
K853158	DIGITAL SPHYGMOMANOMETER MODEL 7620	Takeda Medical, Inc.	1985-11-14	107
K851223	COPAL DIGITAL SPHYGMOMANOMETER UA-560	Takeda Medical, Inc.	1985-09-09	167
K852564	COPAL UA-512 DIGITAL BLOOD PRESSURE MONITOR	Takeda Medical, Inc.	1985-08-19	91
K843390	COPAL DIGITAL SPHYGMOMANOMETER UA-535	Takeda Medical, Inc.	1985-05-15	259
K844285	COPAL DIGITAL SPHYGMOMAMOMETER UA-550	Takeda Medical, Inc.	1985-04-18	164
K842388	COPAL DIGITAL SPHYGMOMANOMETER UA-510	Takeda Medical, Inc.	1985-02-13	240
K844284	COPAL DIGITAL SPHYGMOMANOMETER UA-540	Takeda Medical, Inc.	1985-02-08	95
K850196	COPAL DIGITAL THERMOMETER UF-22B	Takeda Medical, Inc.	1985-02-07	20
K850195	COPAL DIGITAL THERMOMETER UF-12	Takeda Medical, Inc.	1985-02-07	20
K843040	COPAL DIGITAL THERMOMETER UF-10	Takeda Medical, Inc.	1985-01-03	154

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