Biosphere Medical, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Biosphere Medical, Inc.” (first 2000, latest 2012), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 186 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 | 1 | 72 |
| 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 |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | 3 | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| KRD | Device, Vascular, For Promoting Embolization | 1 | 1 |
| NAJ | Agents, Embolic, For Treatment Of Uterine Fibroids | 1 | 1 |
Review panels
- Cardiovascular (4)
- Neurology (3)
- Obstetrics and Gynecology (1)
Most recent Biosphere Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113822 | QUADRASPHERE 30 TO 60 | HCG | 2012-03-08 | 72 |
| K052742 | HEPASPHERE MICROSPHERES | KRD | 2006-11-07 | 403 |
| K062126 | EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 | DQO | 2006-08-09 | 14 |
| K061171 | SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX | DQX | 2006-06-02 | 36 |
| K021397 | EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION | NAJ | 2002-11-22 | 204 |
| K010026 | EMBOGOLD MICROSPHERE | HCG | 2001-06-21 | 169 |
| K003105 | BIOSPHERE MEDICAL INFUSION CATHETER | DQO | 2001-05-22 | 230 |
| K991549 | EMBOSPHERE MICROSPHERES | HCG | 2000-04-26 | 359 |
Recalls
openFDA lists no recalls under a recalling firm named Biosphere Medical, Inc..
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.
- Biosphere Medical, S.A. (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biosphere Medical, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Biosphere Medical, Inc.” (first 2000, latest 2012), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biosphere Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biosphere Medical, Inc. is 186 days.
Which FDA product codes appear under Biosphere Medical, Inc.?
The most frequent FDA product codes under this applicant name are HCG (Device, Neurovascular Embolization, 3); DQO (Catheter, Intravascular, Diagnostic, 2); DQX (Wire, Guide, Catheter, 1).
Next steps
- See all 8 Biosphere Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HCG, Biosphere Medical, Inc.'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.