Miris AB: FDA clearances and approvals
Miris AB has 1 FDA 510(k) clearance (first 2023, latest 2023), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 364 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 1 | 364 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Miris AB's cleared 510(k)s took a median 364 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 248 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QEI | Breast Milk Macronutrients Test System | 2 | 1 |
Review panels
Most recent Miris AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223085 | Miris Human Milk Analyzer (HMA) | QEI | 2023-09-29 | 364 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180007 | De Novo | Breast Milk Macronutrients Test System | 2018-12-21 |
Recalls
openFDA lists no recalls under a recalling firm named Miris AB.
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 Miris AB have?
Miris AB has 1 FDA 510(k) clearance (first 2023, latest 2023), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Miris AB's 510(k)s?
The median time from FDA receipt to decision across Miris AB's cleared 510(k)s is 364 days.
What devices does Miris AB make?
Its most frequent FDA product codes are QEI (Breast Milk Macronutrients Test System, 2).
Has Miris AB had device recalls?
openFDA lists no recalls under a recalling firm name matching Miris AB. Related entities may recall under other names.
Next steps
- See all 1 Miris AB clearances with predicates and recalls
- Run predicate analysis for product code QEI, Miris AB'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.