Bivona Medical Technologies: FDA filings under this applicant name
FDA lists 50 510(k) clearances under the applicant name “Bivona Medical Technologies” (first 1978, latest 1995), across 16 product codes in 4 review panels. Median 510(k) review time under this name: 63 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 |
|---|---|---|---|
| JOH | Tube Tracheostomy And Tube Cuff | 15 | 15 |
| BTR | Tube, Tracheal (W/Wo Connector) | 8 | 8 |
| EWL | Prosthesis, Laryngeal (Taub) | 8 | 8 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 6 | 6 |
| EMX | Balloon, Epistaxis | 2 | 2 |
| BSR | Stylet, Tracheal Tube | 1 | 1 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 1 | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
| FAD | Stent, Ureteral | 1 | 1 |
Plus 6 more product codes.
Review panels
- Anesthesiology (33)
- Ear, Nose and Throat (12)
- Gastroenterology and Urology (4)
- Obstetrics and Gynecology (1)
Most recent Bivona Medical Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952700 | SUPERSLICK | JOH | 1995-10-31 | 140 |
| K942025 | BURGET NASAL STENT | LWF | 1995-10-27 | 549 |
| K944178 | BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES | JOH | 1994-10-27 | 62 |
| K935053 | BIVONA NASAL TURBINATE STENT | LYA | 1994-07-01 | 253 |
| K933398 | BIVONA ILLUMINATED ENDOTRACHEAL TUBE | BTR | 1993-10-06 | 86 |
| K931749 | BIVONA(R) ICU ENDOTRACHEAL TUBE | BTR | 1993-08-10 | 124 |
| K922665 | BIVONA HYPERFLEX TRACHEOSTOMY TUBE | JOH | 1993-01-07 | 220 |
| K923878 | BIVONA CUSTOMIZED TRACHEOSTOMY TUBES | JOH | 1992-12-29 | 148 |
| K920604 | BIVONA TRACHEAL T-TUBE STENT | BTO | 1992-07-27 | 167 |
| K915761 | BIVONA-COLORADO VOICE PROSTHESIS | EWL | 1992-06-29 | 188 |
40 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bivona Medical Technologies.
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 Bivona Medical Technologies?
FDA lists 50 510(k) clearances under the applicant name “Bivona Medical Technologies” (first 1978, latest 1995), across 16 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 Bivona Medical Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bivona Medical Technologies is 63 days.
Which FDA product codes appear under Bivona Medical Technologies?
The most frequent FDA product codes under this applicant name are JOH (Tube Tracheostomy And Tube Cuff, 15); BTR (Tube, Tracheal (W/Wo Connector), 8); EWL (Prosthesis, Laryngeal (Taub), 8).
Next steps
- See all 50 Bivona Medical Technologies clearances with predicates and recalls
- Run predicate analysis for product code JOH, Bivona Medical Technologies'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.