The Medi-Dose Group: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “The Medi-Dose Group” (first 1989, latest 1995), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 100 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 6 | 6 |
| FMF | Syringe, Piston | 3 | 3 |
| FPB | Filter, Infusion Line | 1 | 1 |
Review panels
- General Hospital (10)
Most recent The Medi-Dose Group 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952242 | TRANSFEER SPIKE II | FPA | 1995-09-15 | 126 |
| K942625 | 1.2 MICRON AIR ELIMINATING FILTER | FPB | 1994-10-07 | 127 |
| K900651 | TS-1800 MEDICATION TRANSFER SPIKE | FPA | 1990-05-07 | 87 |
| K895291 | IV DISPESNSING SPIKE | FPA | 1989-12-27 | 124 |
| K895290 | CHEMO-SPIKE RECONSTITUTION DEVICE | FPA | 1989-12-27 | 124 |
| K896291 | INJECTION PORT II --- FOR INTERMITTENT INJECTION | FPA | 1989-12-01 | 31 |
| K895419 | DISPOSABLE DISC FILTER | FMF | 1989-11-24 | 84 |
| K892429 | INJECTION PORT FOR---INTERMITTENT INJECTION | FPA | 1989-07-25 | 106 |
| K892430 | DISPOSABLE DISC FILTER | FMF | 1989-07-14 | 95 |
| K892428 | COMBI-CAP | FMF | 1989-07-14 | 95 |
Recalls
openFDA lists no recalls under a recalling firm named The Medi-Dose Group.
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 The Medi-Dose Group?
FDA lists 10 510(k) clearances under the applicant name “The Medi-Dose Group” (first 1989, latest 1995), across 3 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 The Medi-Dose Group?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Medi-Dose Group is 100 days.
Which FDA product codes appear under The Medi-Dose Group?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 6); FMF (Syringe, Piston, 3); FPB (Filter, Infusion Line, 1).
Next steps
- See all 10 The Medi-Dose Group clearances with predicates and recalls
- Run predicate analysis for product code FPA, The Medi-Dose Group'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.