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

LDZ — Predicate Candidate Screening

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

32 daysmedian FDA review time

406 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K883048	ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION	Alpha-Tec Systems, Inc.	1988-08-17	32
K881922	CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE	Surgipath Medical Industries, Inc.	1988-05-25	16
K881698	ATS PVA FIXATIVE SOLUTION	Alpha-Tec Systems, Inc.	1988-05-13	24
K862725	SACCOMANNO SPECIMAN SOLUTION	Mill-Rose Laboratory	1986-08-01	15
K843428	BIOFIX	Accra Laboratories, Inc.	1984-09-27	23
K842913	WRIGHT STAIN FIXATIVE	E K Ind., Inc.	1984-09-07	44
K831061	PVA FIXATIVE/FORMALIN	American Micro Scan	1983-06-08	68
K761138	FA TISSUE FIXATIVE & WASH SET	Zeus Scientific, Inc.	1978-01-06	406

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