Astute Medical, Inc.: FDA clearances and approvals
Astute Medical, Inc. has 2 FDA 510(k) clearances (first 2016, latest 2017), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 196 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 212 |
| 2017 | 1 | 181 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Astute Medical, Inc.'s cleared 510(k)s took a median 181 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 181 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PIG | Acute Kidney Injury Test System | 3 | 2 |
Review panels
Most recent Astute Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171482 | NEPHROCHECK Test System | PIG | 2017-11-16 | 181 |
| K153165 | NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit | PIG | 2016-06-01 | 212 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130031 | De Novo | Acute Kidney Injury Test System | 2014-09-05 |
Recalls
openFDA lists no recalls under a recalling firm named Astute Medical, 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 Astute Medical, Inc. have?
Astute Medical, Inc. has 2 FDA 510(k) clearances (first 2016, latest 2017), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Astute Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Astute Medical, Inc.'s cleared 510(k)s is 196 days.
What devices does Astute Medical, Inc. make?
Its most frequent FDA product codes are PIG (Acute Kidney Injury Test System, 3).
Has Astute Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Astute Medical, Inc. Related entities may recall under other names.
Next steps
- See all 2 Astute Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PIG, Astute Medical, 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.