Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aesku, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
134 daysmedian FDA review time
247 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062217 | AESKULSKA BETA2-GLYCO-A | Aesku, Inc. | 2006-12-13 | 134 | 0 |
| K051492 | AESKULISA ASCA A | Aesku, Inc. | 2005-11-14 | 161 | 0 |
| K042644 | AESKULISA TTG A AND AESKULISA TTG G | Aesku, Inc. | 2005-06-01 | 247 | 0 |
| K040953 | AESKULISA ANA HEP-2 | Aesku, Inc. | 2004-06-23 | 72 | 0 |
| K040463 | AESKULISA CARDIOLIPIN AGM | Aesku, Inc. | 2004-05-12 | 79 | 0 |
| K032469 | AESKULISA ANA 8PRO | Aesku, Inc. | 2003-12-16 | 127 | 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