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

JCE — Predicate Candidate Screening

7 FDA 510(k) clearances under this product code; the 50 most recent screened below.

40 daysmedian FDA review time

60 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K842722	BUFFERED SALINE	E K Ind., Inc.	1984-09-11	60
K831200	IMMUNOHEMATOLOGICAL SALINE #97139	Emd Chemicals, Inc.	1983-05-09	28
K801506	CERTIFIED BLOOD BANK SALINE	Nobel Scientific Industries, Inc.	1980-07-28	28
K792101	COUITER/CMS ISOTONIC BLOOD BANK SALINE	Coulter Electronics, Inc.	1979-11-20	32
K761183	LYSING AGENT AF	Central Labs. Assoc. MD Pathologists	1977-01-17	46
K761174	PHYSIOLOGIC SALINE (0.85%)	Bio/Data Corp.	1977-01-10	40
K761170	BARBITAL SALINE BUFFER	Bio/Data Corp.	1977-01-10	40

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