Bio-Plexus, Inc.: FDA clearances and approvals
Bio-Plexus, Inc. has 6 FDA 510(k) clearances (first 1990, latest 2001), across 1 product code in 1 review panel. Median 510(k) review time: 130 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 6 | 6 |
Review panels
- General Hospital (6)
Most recent Bio-Plexus, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003827 | PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION | FMI | 2001-01-08 | 28 |
| K992091 | PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750 | FMI | 1999-09-09 | 80 |
| K963748 | BIO-PLEXUS DROP-IT NEEDLE HOLDER | FMI | 1997-06-06 | 262 |
| K960933 | BIO-PLEXUS NEEDLE DISPOSAL CONTAINER | FMI | 1996-08-28 | 174 |
| K961251 | PUNCTUR-GUARD WINGED SET | FMI | 1996-06-27 | 87 |
| K895024 | PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE | FMI | 1990-09-21 | 409 |
Recalls
openFDA lists no recalls under a recalling firm named Bio-Plexus, 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 Bio-Plexus, Inc. have?
Bio-Plexus, Inc. has 6 FDA 510(k) clearances (first 1990, latest 2001), across 1 product code in 1 review panel.
How long does FDA take to clear Bio-Plexus, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Bio-Plexus, Inc.'s cleared 510(k)s is 130 days.
What devices does Bio-Plexus, Inc. make?
Its most frequent FDA product codes are FMI (Needle, Hypodermic, Single Lumen, 6).
Has Bio-Plexus, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bio-Plexus, Inc. Related entities may recall under other names.
Next steps
- See all 6 Bio-Plexus, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Bio-Plexus, 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.