Bipore, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Bipore, Inc.” (first 1985, latest 2008), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 116 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 5 | 5 |
| DYB | Introducer, Catheter | 3 | 3 |
| FIB | Protector, Transducer, Dialysis | 1 | 1 |
| KOZ | Beads, Hydrophilic, For Wound Exudate Absorption | 1 | 1 |
Review panels
Most recent Bipore, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K073434 | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER | DYB | 2008-04-01 | 117 |
| K073318 | BIPORE BALLOON DILATION CATHETER | LIT | 2008-01-16 | 51 |
| K051513 | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER | DYB | 2005-12-07 | 188 |
| K041293 | BIOPORE BALLOON DILATION CATHETER | LIT | 2004-07-09 | 56 |
| K983650 | BIPORE BALLOON DILATATION CATHETER | LIT | 1999-02-17 | 124 |
| K973563 | BIPORE BALLOON DILATATION CATHETER | LIT | 1998-04-01 | 194 |
| K964814 | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER | DYB | 1997-05-07 | 159 |
| K961980 | BIPORE BALLOON DILATATION CATHETER | LIT | 1996-09-12 | 115 |
| K862015 | O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER | FIB | 1986-07-22 | 55 |
| K844625 | BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY | KOZ | 1985-01-16 | 50 |
Recalls
openFDA lists no recalls under a recalling firm named Bipore, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bipore, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Bipore, Inc.” (first 1985, latest 2008), across 4 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 Bipore, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bipore, Inc. is 116 days.
Which FDA product codes appear under Bipore, Inc.?
The most frequent FDA product codes under this applicant name are LIT (Catheter, Angioplasty, Peripheral, Transluminal, 5); DYB (Introducer, Catheter, 3); FIB (Protector, Transducer, Dialysis, 1).
Next steps
- See all 10 Bipore, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LIT, Bipore, 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.