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

IFP — Predicate Candidate Screening

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

28 daysmedian FDA review time

57 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K884755	CONSED FECAL CONCENTRATION SYSTEM	Donald L. Price, Ph.D.	1989-01-10	57
K872663	DRY-FORM	Anatech, Ltd.	1987-08-06	29
K872140	(MSI) PATH-SAVER	Medical Specialties, Inc.	1987-06-15	13
K870852	NBF 10% NEUTRAL BUFFERED FORMALIN	Anatech, Ltd.	1987-03-31	28
K853497	PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN	Surgipath Medical Industries, Inc.	1985-08-28	8
K842982	FORMALIN BUFFERED	Reagent Laboratory, Inc.	1984-10-01	63
K842940	CBA FORMALIN	Anatech, Ltd.	1984-08-28	34
K842728	BUF-FIX	E K Ind., Inc.	1984-08-03	21
K840926	FORMALIN SOLUTION 10% NEUTRAL BUFFER	Sigma Chemical Co.	1984-03-12	10
K830582	MILLONIG'S MODIFIED PHOSPHATE BUFFERED	Surgipath Medical Industries, Inc.	1983-03-17	22
K830583	NEUTRAL BUFFERED FORMALIN 10%	Surgipath Medical Industries, Inc.	1983-03-17	22
K830514	MILLONIGS MODIFIED PHOSPHATE BUFFERED	Surgipath Medical Industries, Inc.	1983-03-08	19
K812940	10% NEUTRAL BUFFERED FORMALIN CONCENT	Surgipath	1981-12-10	51
K812817	NEUTRAL DUFFERED FORMA-SCENT	Meridian Diagnostics, Inc.	1981-11-10	34
K811795	10% NEUTRAL BUFFERED FORMALDEHYDE	Richard-Allan Medical Ind., Inc.	1981-07-28	34

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