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

PJD — Predicate Candidate Screening

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

123 daysmedian FDA review time

458 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K232898	Quantisal™ Oral Fluid Collection Device	Immunalysis Corporation	2023-11-21	64	0
K223781	Quantisal™ II Oral Fluid Collection Device	Immunalysis Corporation	2023-07-28	224	0
K200801	Quantisal Oral Fluid Collection Device	Immunalysis Corporation	2020-07-28	123	0
K183048	Quantisal II Oral Fluid Collection Device	Immunalysis Corporation	2019-07-29	269	0
K011057	INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVI	OraSure Technologies, Inc.	2001-06-06	61	0
K984361	ORAL-EZE ORAL FLUID COLLECTION SYSTEM	Osborn Laboratories, Inc.	1999-01-13	37	1
K973395	EPISCREEN ORAL SPECIMEN COLLECTION DEVICE	Epitope, Inc.	1998-02-13	176	0
K970357	EPISCREEN	Epitope, Inc.	1997-03-10	39	0
K942435	SALIVA SAMPLER	Saliva Diagnostic Systems, Inc.	1995-08-21	458	0

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