Biosphere Medical, S.A.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Biosphere Medical, S.A.” (first 2015, latest 2025), plus 1 De Novo decision, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 72 days. Since 2017 the median was 72 days, against 104 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2015 | 2 | 56 |
| 2016 | 0 | — |
| 2017 | 1 | 30 |
| 2018 | 2 | 112 |
| 2019 | 3 | 179 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 46 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biosphere Medical, S.A. took a median 72 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KRD | Device, Vascular, For Promoting Embolization | 9 | 9 |
| NOY | Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia | 1 | 0 |
Review panels
Most recent Biosphere Medical, S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250971 | Embosphere Microspheres | KRD | 2025-05-16 | 46 |
| K192480 | Torpedo Gelatin Foam | KRD | 2019-11-21 | 72 |
| K183120 | EmboCube Embolization Gelatin | KRD | 2019-08-06 | 270 |
| K183578 | Torpedo Gelatin Foam | KRD | 2019-06-18 | 179 |
| K181021 | EmboCube Embolization Gelatin | KRD | 2018-09-27 | 163 |
| K181300 | Embosphere Microspheres | KRD | 2018-07-16 | 60 |
| K172372 | QuadraSphere Microspheres | KRD | 2017-09-06 | 30 |
| K153102 | QuadraSphere Microspheres | KRD | 2015-11-23 | 28 |
| K151187 | QuadraSphere Microspheres | KRD | 2015-07-27 | 84 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN160040 | De Novo | Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia | 2017-06-21 |
Recalls
openFDA lists no recalls under a recalling firm named Biosphere Medical, S.A..
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, Inc. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biosphere Medical, S.A.?
FDA lists 9 510(k) clearances under the applicant name “Biosphere Medical, S.A.” (first 2015, latest 2025), plus 1 De Novo decision, across 2 product codes in 2 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, S.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biosphere Medical, S.A. is 72 days. Since 2017: 72 days, versus 104 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Biosphere Medical, S.A.?
The most frequent FDA product codes under this applicant name are KRD (Device, Vascular, For Promoting Embolization, 9); NOY (Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia, 1).
Next steps
- See all 9 Biosphere Medical, S.A. clearances with predicates and recalls
- Run predicate analysis for product code KRD, Biosphere Medical, S.A.'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.