Unoplast A/S: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Unoplast A/S” (first 1980, latest 1990), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 120 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| BZB | Catheter, Nasal, Oxygen | 1 | 1 |
| EXR | Urinometer, Mechanical | 1 | 1 |
| FPD | Tube, Feeding | 1 | 1 |
| GAO | Suture, Nonabsorbable | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
| KOD | Catheter, Urological | 1 | 1 |
Review panels
Most recent Unoplast A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K896734 | FEEDING TUBE | FPD | 1990-12-21 | 386 |
| K896729 | NELATON-, FEMALE - OR TIEMANN CATHETER | KOD | 1990-11-05 | 340 |
| K896732 | UNOMETER 500 | EXR | 1990-11-02 | 337 |
| K896731 | OXYGEN CATHETERS | BZB | 1990-03-30 | 120 |
| K896730 | SUCTION CATHETER STRAIGHT/COUDE | BSY | 1990-03-30 | 120 |
| K896733 | VACCON | KGX | 1990-02-01 | 63 |
| K802248 | DISARP ORIGINAL | GAO | 1980-09-26 | 10 |
Recalls
openFDA lists no recalls under a recalling firm named Unoplast A/S.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Unoplast A/S?
FDA lists 7 510(k) clearances under the applicant name “Unoplast A/S” (first 1980, latest 1990), across 7 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Unoplast A/S?
The median time from FDA receipt to decision across 510(k)s cleared under the name Unoplast A/S is 120 days.
Which FDA product codes appear under Unoplast A/S?
The most frequent FDA product codes under this applicant name are BSY (Catheters, Suction, Tracheobronchial, 1); BZB (Catheter, Nasal, Oxygen, 1); EXR (Urinometer, Mechanical, 1).
Next steps
- See all 7 Unoplast A/S clearances with predicates and recalls
- Run predicate analysis for product code BSY, Unoplast 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, 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.