Blockade Medical: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Blockade Medical” (first 2013, latest 2015), across 1 product code in 1 review panel. Median 510(k) review time under this name: 64 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 |
|---|---|---|
| 2013 | 3 | 64 |
| 2014 | 2 | 48 |
| 2015 | 1 | 28 |
| 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 |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | 6 | 6 |
Review panels
- Neurology (6)
Most recent Blockade Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151760 | Barricade Embolization Coil System | HCG | 2015-07-27 | 28 |
| K142513 | Barricade Embolization Coil System | HCG | 2014-11-13 | 66 |
| K140104 | BARRICADE EMBOLIZATION COIL SYSTEM | HCG | 2014-02-13 | 29 |
| K132482 | BARRICADE EMBOLIZATION COIL SYSTEM | HCG | 2013-10-10 | 63 |
| K131475 | BARRICADE EMBOLIZATION COIL SYSTEM | HCG | 2013-07-25 | 64 |
| K123338 | BARRICADE EMBOLIZATION COIL SYSTEM | HCG | 2013-03-28 | 148 |
Recalls
openFDA lists no recalls under a recalling firm named Blockade 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.
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.
- Blockade Medical, LLC (D.B.A. Balt Usa) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Blockade Medical?
FDA lists 6 510(k) clearances under the applicant name “Blockade Medical” (first 2013, latest 2015), 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 Blockade Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Blockade Medical is 64 days.
Which FDA product codes appear under Blockade Medical?
The most frequent FDA product codes under this applicant name are HCG (Device, Neurovascular Embolization, 6).
Next steps
- See all 6 Blockade Medical clearances with predicates and recalls
- Run predicate analysis for product code HCG, Blockade 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, 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.