Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

KDT — Predicate Candidate Screening

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

41 daysmedian FDA review time

59 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K873593	BIOSURE SPECIMEN COLLECTION CONTAINER	Biosure, Inc.	1987-11-25	82
K862665	NOVACYTE-U	Xsirius Medical, Inc.	1986-09-04	52
K834579	BIOSPAL 2400S	Hospal Medical Corp.	1984-02-04	37
K834412	PRESERV PVA FIXATIVE 15ML-FORMALIN PK	Preventive Diagnostics Corp.	1984-01-13	29
K833660	PRESERV PVA FIXATIVE -MALIN PACK	Preventive Diagnostics Corp.	1983-11-28	41
K823773	PROVIAL II #006-010-0201	Dynatech Corp.	1983-01-21	38
K822870	STOOL-COLLECTION/PRESERVATION KIT	American Scientific Products	1982-11-01	35
K821621	PREGNOPOST	M.M. Wolfred, Ph.D.	1982-07-21	49
K820246	PREFILLED SPECIMEN CONTAINER	Sage Products, Inc.	1982-02-18	20
K811793	FIX-RIGHT 90ML & 180 ML PREFILLED CONT	Richard-Allan Medical Ind., Inc.	1981-07-31	37
K800946	URINARY CATHETER SAMPLING KIT	Sage Products, Inc.	1980-06-20	59
K770071	PINLOCK CONTAINER	Perkins Mfg. Co.	1977-02-24	42

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