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

Aesku Diagnostics — Predicate Candidate Screening

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

153 daysmedian FDA review time

349 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K132082	AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK	Aesku Diagnostics	2013-12-05	153
K120889	AESKUSLIDES ANA HEP-2	Aesku Diagnostics	2012-10-15	206
K091859	AESKU PR3	Aesku Diagnostics	2010-06-03	349
K091860	AESKULISA MPO, MODEL 30-7303US	Aesku Diagnostics	2010-02-23	249
K081251	MODIFICATION TO AESKULISA DS DNA G	Aesku Diagnostics	2008-05-13	11
K081104	AESKULISA ANA HEP-2, REF 30-7115US	Aesku Diagnostics	2008-05-02	14
K052439	AESKULISA GLIA A AND AESKULISA GLIA G	Aesku Diagnostics	2006-02-07	154
K041628	AESKULISA DS DNA G	Aesku Diagnostics	2004-10-14	120
K041753	AESKULISA ENA 6 S	Aesku Diagnostics	2004-07-14	15

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