Aesku, Inc.: FDA clearances and approvals
Aesku, Inc. has 6 FDA 510(k) clearances (first 2003, latest 2006), across 6 product codes in 1 review panel. Median 510(k) review time: 130 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 1 | 1 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 1 | 1 |
| MID | System, Test, Anticardiolipin Immunological | 1 | 1 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 1 | 1 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 1 | 1 |
| NBT | Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) | 1 | 1 |
Review panels
- Immunology (6)
Most recent Aesku, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062217 | AESKULSKA BETA2-GLYCO-A | MSV | 2006-12-13 | 134 |
| K051492 | AESKULISA ASCA A | NBT | 2005-11-14 | 161 |
| K042644 | AESKULISA TTG A AND AESKULISA TTG G | MVM | 2005-06-01 | 247 |
| K040953 | AESKULISA ANA HEP-2 | LJM | 2004-06-23 | 72 |
| K040463 | AESKULISA CARDIOLIPIN AGM | MID | 2004-05-12 | 79 |
| K032469 | AESKULISA ANA 8PRO | LLL | 2003-12-16 | 127 |
Recalls
openFDA lists no recalls under a recalling firm named Aesku, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Aesku, Inc. have?
Aesku, Inc. has 6 FDA 510(k) clearances (first 2003, latest 2006), across 6 product codes in 1 review panel.
How long does FDA take to clear Aesku, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Aesku, Inc.'s cleared 510(k)s is 130 days.
What devices does Aesku, Inc. make?
Its most frequent FDA product codes are LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, 1); LLL (Extractable Antinuclear Antibody, Antigen And Control, 1); MID (System, Test, Anticardiolipin Immunological, 1).
Has Aesku, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Aesku, Inc. Related entities may recall under other names.
Next steps
- See all 6 Aesku, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJM, Aesku, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.