Equashield Medical , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Equashield Medical , Ltd.” (first 2010, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 239 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 | 1 | 239 |
| 2015 | 1 | 279 |
| 2016 | 0 | — |
| 2017 | 1 | 117 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 268 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Equashield Medical , Ltd. took a median 192 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 193 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | 4 | 4 |
| LHI | Set, I.V. Fluid Transfer | 1 | 1 |
Review panels
- General Hospital (5)
Most recent Equashield Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221513 | Equashield Closed System Transfer Device | ONB | 2023-02-17 | 268 |
| K170706 | Equashield Closed System drug Transfer Device (CSTD) | ONB | 2017-07-03 | 117 |
| K150219 | Equashield Closed System drug Transfer Device (CSTD) | ONB | 2015-11-05 | 279 |
| K132899 | EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) | ONB | 2014-05-13 | 239 |
| K101940 | EQUASHIELD SYSTEM PROTECTIVE PLUS | LHI | 2010-11-19 | 130 |
Recalls
openFDA lists no recalls under a recalling firm named Equashield Medical , Ltd..
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 Equashield Medical , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Equashield Medical , Ltd.” (first 2010, latest 2023), 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 Equashield Medical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Equashield Medical , Ltd. is 239 days.
Which FDA product codes appear under Equashield Medical , Ltd.?
The most frequent FDA product codes under this applicant name are ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System, 4); LHI (Set, I.V. Fluid Transfer, 1).
Next steps
- See all 5 Equashield Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code ONB, Equashield Medical , 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.