Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Biological Corp. of America · Predicate Candidate Screening

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

47 daysmedian FDA review time

119 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days
K813404	FREEZE DRIED FICIN	Biological Corp. of America	1982-02-10	65
K812565	ELUTION SOLUTION	Biological Corp. of America	1981-10-23	44
K812222	EM-X	Biological Corp. of America	1981-09-23	47
K810803	FREEZE DRIED PAPAIN	Biological Corp. of America	1981-07-21	119
K781397	EM-V	Biological Corp. of America	1978-09-14	34
K760162	HEMATOLOGY CONTROL	Biological Corp. of America	1976-08-04	29

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