Unomedical A/S: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Unomedical A/S” (first 2003, latest 2021), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 75 days. Since 2017 the median was 111 days, against 205 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Convatec, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 13 |
| 2013 | 1 | 89 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 156 |
| 2017 | 1 | 391 |
| 2018 | 1 | 74 |
| 2019 | 1 | 80 |
| 2020 | 0 | — |
| 2021 | 1 | 142 |
| 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 Unomedical A/S took a median 111 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 205 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 12 | 12 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
Review panels
- General Hospital (13)
Most recent Unomedical A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210544 | Medtronic Extended infusion set | FPA | 2021-07-16 | 142 |
| K192647 | neria guard Infusion Set | FPA | 2019-12-13 | 80 |
| K173879 | MiniMed Mio Advance infusion set | FPA | 2018-03-05 | 74 |
| K162812 | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set | FPA | 2017-11-01 | 391 |
| K160648 | MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® | FPA | 2016-08-10 | 156 |
| K132142 | NERIA SOFT 90 INFUSION SET | FPA | 2013-10-08 | 89 |
| K120337 | I-PORT ADVANCE INJECTION PORT | FOZ | 2012-02-16 | 13 |
| K070430 | PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS | FPA | 2007-04-04 | 50 |
| K061374 | INTUITION INFUSION SETS | FPA | 2006-07-31 | 75 |
| K051264 | COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS | FPA | 2005-09-01 | 108 |
3 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 4 recall events; 6 initiated in the last five years. Most recent: 2024-07-23.
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.
- Unomedical Sdn Bhd (9 510(k)s)
- Unomedical A/S Infusion Devices (1 510(k)s)
- Unomedical Devices S.A DE C.V. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Unomedical A/S?
FDA lists 13 510(k) clearances under the applicant name “Unomedical A/S” (first 2003, latest 2021), across 2 product codes 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 Unomedical A/S?
The median time from FDA receipt to decision across 510(k)s cleared under the name Unomedical A/S is 75 days. Since 2017: 111 days, versus 205 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Unomedical A/S?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 12); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 1).
Next steps
- See all 13 Unomedical A/S clearances with predicates and recalls
- Run predicate analysis for product code FPA, Unomedical A/S'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.