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

JCC — Predicate Candidate Screening

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

47 daysmedian FDA review time

62 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K842918	SCOTTS TAP WATER SUBSTITUTE	E K Ind., Inc.	1984-09-11	48
K842914	WRIGHT STAIN BUFFER	E K Ind., Inc.	1984-09-07	44
K841423	SCOTTS TAP WATER SUBSTITUTE 7	Reagent Laboratory, Inc.	1984-05-22	47
K811791	PHOSPHATE BUFFERED SALINE (1X)	Dutchland Laboratories, Inc.	1981-08-25	62
K811251	CITRATE BUFFER	Bioscientific	1981-05-21	16
K792574	MOPSO BUFFER	Electrophoresis Corp. of America	1980-01-21	39
K770508	SMAC SYSTEM	Mid Tech, Inc.	1977-05-09	53

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