Biosurge, Inc.: FDA clearances and approvals
Biosurge, Inc. has 5 FDA 510(k) clearances (first 1987, latest 1988), across 3 product codes in 2 review panels. Median 510(k) review time: 70 days.
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 |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
Review panels
- Cardiovascular (3)
- General Hospital (2)
Most recent Biosurge, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K884620 | ASD SINGLE LUMEN NEEDLE | FMI | 1988-11-21 | 17 |
| K875016 | BIOSURGE MODEL ILVC-1 | DWS | 1988-02-29 | 87 |
| K874602 | ASD-BIO ANTI-STICK DEVICE | FMI | 1988-02-19 | 102 |
| K875023 | BIOSURGE MODEL OASYS-II | CAC | 1988-02-12 | 70 |
| K871258 | BIOSURGE MODEL OASYS | CAC | 1987-05-21 | 51 |
Recalls
openFDA lists no recalls under a recalling firm named Biosurge, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Biosurge, Inc. have?
Biosurge, Inc. has 5 FDA 510(k) clearances (first 1987, latest 1988), across 3 product codes in 2 review panels.
How long does FDA take to clear Biosurge, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Biosurge, Inc.'s cleared 510(k)s is 70 days.
What devices does Biosurge, Inc. make?
Its most frequent FDA product codes are CAC (Apparatus, Autotransfusion, 2); FMI (Needle, Hypodermic, Single Lumen, 2); DWS (Instruments, Surgical, Cardiovascular, 1).
Has Biosurge, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Biosurge, Inc. Related entities may recall under other names.
Next steps
- See all 5 Biosurge, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAC, Biosurge, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.