Bio D Corp.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Bio D Corp.” (first 1980, latest 1980), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 45 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 | 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 |
|---|---|---|---|
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 9 | 9 |
| KME | Bedding, Disposable, Medical | 2 | 2 |
Review panels
Most recent Bio D Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K802739 | URINE COLLECTION BAG TYPE 710AP | KNX | 1980-12-18 | 45 |
| K802738 | URINE COLLECTION BAG TYPE 1505V | KNX | 1980-12-18 | 45 |
| K802737 | URINE COLLECTION BAG TYPE 1590V | KNX | 1980-12-18 | 45 |
| K802736 | URINE COOLECTION BAG TYPE 2090V | KNX | 1980-12-18 | 45 |
| K802735 | URINE COLLECTION BAG TYPE 740AP | KNX | 1980-12-18 | 45 |
| K802734 | URINE COLLECTION BAG TYPE 710 | KNX | 1980-12-18 | 45 |
| K802733 | URINE COLLECTION BAG TYPE AP2090V | KNX | 1980-12-18 | 45 |
| K802732 | URINE COLLECTION BAG TYPE AP2132V | KNX | 1980-12-18 | 45 |
| K802729 | URINE COLLECTION BAG TYPE 2132V | KNX | 1980-12-18 | 45 |
| K802740 | FLUFF UNDERPAD TYPE UP1001 | KME | 1980-12-10 | 37 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bio D Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bio D Corp.?
FDA lists 11 510(k) clearances under the applicant name “Bio D Corp.” (first 1980, latest 1980), 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 Bio D Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio D Corp. is 45 days.
Which FDA product codes appear under Bio D Corp.?
The most frequent FDA product codes under this applicant name are KNX (Collector, Urine, (And Accessories) For Indwelling Catheter, 9); KME (Bedding, Disposable, Medical, 2).
Next steps
- See all 11 Bio D Corp. clearances with predicates and recalls
- Run predicate analysis for product code KNX, Bio D Corp.'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.