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

Advocacy International, Ltd. · Predicate Candidate Screening

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

58 daysmedian FDA review time

124 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K874027	LIPASE UV [TOYO]	Advocacy International, Ltd.	1988-05-27	238
K873792	SEPACELL R-500 AND SEPACELL R-500A	Advocacy International, Ltd.	1988-01-19	124
K855251	MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS	Advocacy International, Ltd.	1986-02-04	36
K855212	ASAHI AM SERIES DIALYZERS	Advocacy International, Ltd.	1986-01-21	22
K854259	SEPACELL R-500 & SEPACELL R-500A	Advocacy International, Ltd.	1986-01-08	77
K842103	TOYO JOZO URIC ACID TEST	Advocacy International, Ltd.	1984-08-12	79
K842104	TOYO JOZO G-GTP TEST	Advocacy International, Ltd.	1984-08-10	77
K830231	ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES	Advocacy International, Ltd.	1983-03-17	58
K830183	ASAHI HOLLOW FIBER KIDNEYS NR SERIES	Advocacy International, Ltd.	1983-03-17	58
K823733	EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR	Advocacy International, Ltd.	1983-01-14	32
K813037	FLOWGUARD CATHETERS & CANNALAE	Advocacy International, Ltd.	1981-12-14	47
K813035	POLYSTAN VERTICLUDE BLOOD PUMP	Advocacy International, Ltd.	1981-11-27	30
K813034	POLYSTAN HEART LUNG MACHINE SYS	Advocacy International, Ltd.	1981-11-27	30

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