Simplivia Healthcare , Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Simplivia Healthcare , Ltd.” (first 2020, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 144 days. Since 2017 the median was 144 days, against 184 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 213 |
| 2021 | 2 | 250 |
| 2022 | 0 | — |
| 2023 | 1 | 90 |
| 2024 | 0 | — |
| 2025 | 2 | 60 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Simplivia Healthcare , Ltd. took a median 144 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 184 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | 6 | 6 |
Review panels
- General Hospital (6)
Most recent Simplivia Healthcare , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253033 | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor | ONB | 2025-10-21 | 29 |
| K251411 | Chemfort Female Luer Lock Adaptor | ONB | 2025-08-05 | 90 |
| K231286 | Chemfort® Catheter Adaptor | ONB | 2023-08-02 | 90 |
| K210707 | OnGuard2 Chemfort Closed Administration (CADM) | ONB | 2021-09-23 | 197 |
| K201142 | TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set | ONB | 2021-02-25 | 302 |
| K192866 | Chemfort CSTD | ONB | 2020-05-07 | 213 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-03-08.
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 Simplivia Healthcare , Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Simplivia Healthcare , Ltd.” (first 2020, latest 2025), 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 Simplivia Healthcare , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Simplivia Healthcare , Ltd. is 144 days. Since 2017: 144 days, versus 184 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Simplivia Healthcare , Ltd.?
The most frequent FDA product codes under this applicant name are ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System, 6).
Next steps
- See all 6 Simplivia Healthcare , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code ONB, Simplivia Healthcare , Ltd.'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.