Promedical , Ltd.: FDA clearances and approvals
Promedical , Ltd. has 5 FDA 510(k) clearances (first 1994, latest 1995), across 3 product codes in 3 review panels. Median 510(k) review time: 28 days.
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 |
|---|---|---|---|
| FCG | Biopsy Needle | 3 | 3 |
| GDF | Guide, Needle, Surgical | 1 | 1 |
| LWE | Bone Marrow Collection/Transfusion Kit | 1 | 1 |
Review panels
Most recent Promedical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954596 | PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM | FCG | 1995-10-07 | 4 |
| K952350 | JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN) | LWE | 1995-07-17 | 59 |
| K951598 | PRO-B BIOPSY NEEDLE | FCG | 1995-04-21 | 14 |
| K944944 | CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE | FCG | 1994-12-21 | 75 |
| K944942 | BREAST LESION LOCALIZATION NEEDLE | GDF | 1994-11-04 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Promedical , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Promedical , Ltd. have?
Promedical , Ltd. has 5 FDA 510(k) clearances (first 1994, latest 1995), across 3 product codes in 3 review panels.
How long does FDA take to clear Promedical , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Promedical , Ltd.'s cleared 510(k)s is 28 days.
What devices does Promedical , Ltd. make?
Its most frequent FDA product codes are FCG (Biopsy Needle, 3); GDF (Guide, Needle, Surgical, 1); LWE (Bone Marrow Collection/Transfusion Kit, 1).
Has Promedical , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Promedical , Ltd. Related entities may recall under other names.
Next steps
- See all 5 Promedical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FCG, Promedical , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.