Brosmed Medical: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Brosmed Medical” (first 2014, latest 2014), across 1 product code in 1 review panel. Median 510(k) review time under this name: 209 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 |
|---|---|---|
| 2014 | 2 | 209 |
| 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 |
|---|---|---|---|
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 2 | 2 |
Review panels
- Cardiovascular (2)
Most recent Brosmed Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133852 | APOLLO BALLOON DILATATION CATHETER | LOX | 2014-09-19 | 274 |
| K141025 | ARTIMES BALLOON DILATATION CATHETER | LOX | 2014-09-12 | 144 |
Recalls
openFDA lists no recalls under a recalling firm named Brosmed Medical.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Brosmed Medical (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
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.
- Brosmed Medical Co., Ltd. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Brosmed Medical?
FDA lists 2 510(k) clearances under the applicant name “Brosmed Medical” (first 2014, latest 2014), across 1 product code 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 Brosmed Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Brosmed Medical is 209 days.
Which FDA product codes appear under Brosmed Medical?
The most frequent FDA product codes under this applicant name are LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous, 2).
Next steps
- See all 2 Brosmed Medical clearances with predicates and recalls
- Run predicate analysis for product code LOX, Brosmed Medical'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.