The Boston Medical Group: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “The Boston Medical Group” (first 1982, latest 1982), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 51 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 | 3 | 3 |
| BRZ | Set, Blood Transfusion | 2 | 2 |
Review panels
- General Hospital (5)
Most recent The Boston Medical Group 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K822410 | BOSTON BLOOD DONOR SETS | BRZ | 1982-09-30 | 51 |
| K822409 | BOSTON BLOOD TRANSFUSION SETS | BRZ | 1982-09-30 | 51 |
| K822408 | BOSTON INFUSION SETS | FPA | 1982-09-30 | 51 |
| K822407 | BOSTON SCALP VEIN INFUSION SETS | FPA | 1982-09-30 | 51 |
| K822406 | BOSTON SOLUTION INFUSION SETS | FPA | 1982-09-30 | 51 |
Recalls
openFDA lists no recalls under a recalling firm named The Boston Medical 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 Boston Medical Group?
FDA lists 5 510(k) clearances under the applicant name “The Boston Medical Group” (first 1982, latest 1982), 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 The Boston Medical Group?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Boston Medical Group is 51 days.
Which FDA product codes appear under The Boston Medical Group?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 3); BRZ (Set, Blood Transfusion, 2).
Next steps
- See all 5 The Boston Medical Group clearances with predicates and recalls
- Run predicate analysis for product code FPA, The Boston Medical 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.