Medimop Medical Projects, Ltd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Medimop Medical Projects, Ltd.” (first 1996, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 70 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 | 1 | 85 |
| 2013 | 2 | 112 |
| 2014 | 1 | 80 |
| 2015 | 0 | — |
| 2016 | 1 | 70 |
| 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | 11 | 11 |
| FMF | Syringe, Piston | 1 | 1 |
Review panels
- General Hospital (12)
Most recent Medimop Medical Projects, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160503 | Vented Vial Adapter Transfer Device - 13mm | LHI | 2016-05-04 | 70 |
| K140730 | VIAL2BAG DIRECT CONNECT | LHI | 2014-06-12 | 80 |
| K130179 | MP VIAL ADAPTER 13MM | LHI | 2013-08-08 | 195 |
| K132040 | VIAL CONNECTOR 13MM CLOSED COLLAR | LHI | 2013-07-31 | 29 |
| K122023 | MIXJECT WITH SPRAY HEAD | FMF | 2012-10-04 | 85 |
| K072759 | VIAL2BAG | LHI | 2007-12-13 | 76 |
| K072511 | SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM | LHI | 2007-12-13 | 98 |
| K062482 | VENTED VIAL ADAPTER TRANSFER DEVICE | LHI | 2006-11-03 | 71 |
| K031861 | MIX2VIAL TRANSFER DEVICE | LHI | 2003-07-29 | 43 |
| K001831 | NEEDLELESS TRANSFER DEVICE | LHI | 2000-07-11 | 25 |
2 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2017-10-06.
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.
- Medimop Medical Project , Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medimop Medical Projects, Ltd.?
FDA lists 12 510(k) clearances under the applicant name “Medimop Medical Projects, Ltd.” (first 1996, latest 2016), 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 Medimop Medical Projects, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medimop Medical Projects, Ltd. is 70 days.
Which FDA product codes appear under Medimop Medical Projects, Ltd.?
The most frequent FDA product codes under this applicant name are LHI (Set, I.V. Fluid Transfer, 11); FMF (Syringe, Piston, 1).
Next steps
- See all 12 Medimop Medical Projects, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LHI, Medimop Medical Projects, 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.