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

LSW — Predicate Candidate Screening

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

120 daysmedian FDA review time

349 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K172348	AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Cri	Aesku.Diagnostics GmbH & Co. KG	2018-02-16	197	0
K152013	QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANT	Inova Diagnostics, Inc.	2016-04-11	265	0
K081251	MODIFICATION TO AESKULISA DS DNA G	Aesku Diagnostics	2008-05-13	11	0
K072393	ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL,	Phadia US, Inc.	2007-12-07	102	1
K060380	FIDIS DSDNA	Biomedical Diagnostics (Bmd) SA	2006-05-02	77	0
K041628	AESKULISA DS DNA G	Aesku Diagnostics	2004-10-14	120	0
K921658	ANTI-DSDNA ANTIBODY TEST	Immco Diagnostics, Inc.	1993-03-22	349	0
K872085	THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS	Immunodiagnostics, Ltd.	1987-09-01	92	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