Bioteque America, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Bioteque America, Inc.” (first 1992, latest 2004), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 204 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 |
|---|---|---|---|
| HHW | Pessary, Vaginal | 3 | 3 |
| DQF | Actuator, Syringe, Injector Type | 1 | 1 |
| HDX | Dilator, Vaginal | 1 | 1 |
| HHK | Curette, Suction, Endometrial (And Accessories) | 1 | 1 |
| HHT | Spatula, Cervical, Cytological | 1 | 1 |
| HIB | Speculum, Vaginal, Nonmetal | 1 | 1 |
| KXP | Stent, Vaginal | 1 | 1 |
| LKF | Cannula, Manipulator/Injector, Uterine | 1 | 1 |
Review panels
Most recent Bioteque America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041094 | HSG CATHETER SET | LKF | 2004-06-17 | 51 |
| K020628 | CURELLE, PREFERRED CURELLE, CUTEQ 2.5 | HHK | 2002-05-24 | 87 |
| K013289 | BIOTEQUE VAGINAL PESSARIES | HHW | 2001-12-27 | 86 |
| K003380 | BIOTEQUE VAGINAL DILATOR | HDX | 2001-01-29 | 90 |
| K920633 | PESSARY FLEXIBLE SILICONE NICHOLS | KXP | 1995-11-08 | 1365 |
| K920747 | PESSARY FLEXIBLE SILICONE DONUT RING | HHW | 1994-08-29 | 922 |
| K933628 | CYTOLOGY BRUSH | HHT | 1994-03-11 | 227 |
| K933521 | SPECULUM | HIB | 1994-03-07 | 230 |
| K920187 | FLEXIBLE SILICONE GELIHORN | HHW | 1992-10-23 | 283 |
| K920177 | VERSA-VIAL | DQF | 1992-07-13 | 181 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2005-02-24.
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 Corp. (14 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bioteque America, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Bioteque America, Inc.” (first 1992, latest 2004), across 8 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 Bioteque America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bioteque America, Inc. is 204 days.
Which FDA product codes appear under Bioteque America, Inc.?
The most frequent FDA product codes under this applicant name are HHW (Pessary, Vaginal, 3); DQF (Actuator, Syringe, Injector Type, 1); HDX (Dilator, Vaginal, 1).
Next steps
- See all 10 Bioteque America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HHW, Bioteque America, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.