Artema Medical AB: FDA clearances and approvals
Artema Medical AB has 5 FDA 510(k) clearances (first 1991, latest 1995), across 1 product code in 1 review panel. Median 510(k) review time: 63 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 |
|---|---|---|---|
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 5 | 5 |
Review panels
- Anesthesiology (5)
Most recent Artema Medical AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945359 | AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H | BYD | 1995-02-21 | 111 |
| K912336 | ARTEMA AQUA+ FLEX | BYD | 1991-07-26 | 63 |
| K912335 | ARTEMA AQUA+ N | BYD | 1991-07-26 | 63 |
| K912334 | ARTEMA AQUA+ T & TS | BYD | 1991-07-26 | 63 |
| K912333 | ARTEMA AQUA+ | BYD | 1991-07-26 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named Artema Medical 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 Artema Medical AB have?
Artema Medical AB has 5 FDA 510(k) clearances (first 1991, latest 1995), across 1 product code in 1 review panel.
How long does FDA take to clear Artema Medical AB's 510(k)s?
The median time from FDA receipt to decision across Artema Medical AB's cleared 510(k)s is 63 days.
What devices does Artema Medical AB make?
Its most frequent FDA product codes are BYD (Condenser, Heat And Moisture (Artificial Nose), 5).
Has Artema Medical AB had device recalls?
openFDA lists no recalls under a recalling firm name matching Artema Medical AB. Related entities may recall under other names.
Next steps
- See all 5 Artema Medical AB clearances with predicates and recalls
- Run predicate analysis for product code BYD, Artema Medical 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.