Dignitana AB: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Dignitana AB” (first 2017, latest 2017), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 102 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 102 |
| 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, 510(k)s cleared under the name Dignitana AB took a median 102 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PMC | Scalp Cooling System | 2 | 1 |
Review panels
Most recent Dignitana AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170871 | DigniCap Scalp Cooling System | PMC | 2017-07-03 | 102 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN150010 | De Novo | Scalp Cooling System | 2015-12-08 |
Recalls
openFDA lists no recalls under a recalling firm named Dignitana AB.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Dignitana, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dignitana AB?
FDA lists 1 510(k) clearance under the applicant name “Dignitana AB” (first 2017, latest 2017), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Dignitana AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dignitana AB is 102 days.
Which FDA product codes appear under Dignitana AB?
The most frequent FDA product codes under this applicant name are PMC (Scalp Cooling System, 2).
Next steps
- See all 1 Dignitana AB clearances with predicates and recalls
- Run predicate analysis for product code PMC, Dignitana AB's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.