Bioteque Corp.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Bioteque Corp.” (first 1992, latest 2025), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 265 days. Since 2017 the median was 266 days, against 196 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 473 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 266 |
| 2021 | 0 | — |
| 2022 | 1 | 426 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 264 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bioteque Corp. took a median 266 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 196 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 4 | 4 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 2 | 2 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| FAD | Stent, Ureteral | 1 | 1 |
| FIE | Needle, Fistula | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| HHK | Curette, Suction, Endometrial (And Accessories) | 1 | 1 |
Review panels
Most recent Bioteque Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G | FGE | 2025-12-22 | 264 |
| K210419 | BIOTEQ Drainage Catheter BT-PDS-series | FGE | 2022-04-13 | 426 |
| K200103 | BIOTEQ Drainage Catheter Set (One Step Type) | FGE | 2020-10-09 | 266 |
| K150932 | Sheath Introducer | DRE | 2016-07-22 | 473 |
| K102633 | BIOTEQ ANGIOGRAPHIC CATHETER | DQO | 2011-09-09 | 361 |
| K033862 | BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK | FGE | 2005-02-14 | 430 |
| K033210 | BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET | FAD | 2004-12-30 | 454 |
| K032292 | BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX | FOZ | 2004-03-22 | 242 |
| K013634 | BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK | FJK | 2002-07-09 | 246 |
| K012526 | BIOTEQUE SCALP VEIN SET | FPA | 2001-09-14 | 39 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bioteque 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.
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.
- Bioteque America, Inc. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bioteque Corp.?
FDA lists 14 510(k) clearances under the applicant name “Bioteque Corp.” (first 1992, latest 2025), across 9 product codes in 4 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 Bioteque Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bioteque Corp. is 265 days. Since 2017: 266 days, versus 196 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bioteque Corp.?
The most frequent FDA product codes under this applicant name are FGE (Stents, Drains And Dilators For The Biliary Ducts, 4); FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve, 2); FPA (Set, Administration, Intravascular, 2).
Next steps
- See all 14 Bioteque Corp. clearances with predicates and recalls
- Run predicate analysis for product code FGE, Bioteque 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.