Venner Medical (Singapore) Pte, Ltd.: FDA clearances and approvals
Venner Medical (Singapore) Pte, Ltd. has 6 FDA 510(k) clearances (first 2010, latest 2020), across 4 product codes in 1 review panel. Median 510(k) review time: 162 days. Since 2017 its median was 192 days, against 238 days for all cleared 510(k)s in the same product codes.
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 | 1 | 46 |
| 2020 | 2 | 253 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Venner Medical (Singapore) Pte, Ltd.'s cleared 510(k)s took a median 192 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 238 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTO | Tube, Tracheostomy (W/Wo Connector) | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 2 | 2 |
| BSK | Cuff, Tracheal Tube, Inflatable | 1 | 1 |
| CCW | Laryngoscope, Rigid | 1 | 1 |
Review panels
- Anesthesiology (6)
Most recent Venner Medical (Singapore) Pte, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192511 | Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 9.0 mm | BTO | 2020-07-22 | 314 |
| K192120 | Venner PneuX ETT (Endotracheal Tube) 6 mm, Venner PneuX ETT (Endotracheal Tube) 7 mm, Venner PneuX ETT (Endotracheal Tube) 8 mm, Venner PneuX ETT (Endotracheal Tube) 9 mm | BTR | 2020-02-14 | 192 |
| K191602 | APA Oxy Blade | CCW | 2019-08-02 | 46 |
| K110631 | VENNER TRACHEAL SEAL MONITOR | BSK | 2011-07-28 | 146 |
| K100950 | VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE | BTO | 2010-07-13 | 98 |
| K093135 | VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE | BTR | 2010-04-02 | 179 |
Recalls
openFDA lists no recalls under a recalling firm named Venner Medical (Singapore) Pte, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Venner Medical (Singapore) Pte, Ltd. have?
Venner Medical (Singapore) Pte, Ltd. has 6 FDA 510(k) clearances (first 2010, latest 2020), across 4 product codes in 1 review panel.
How long does FDA take to clear Venner Medical (Singapore) Pte, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Venner Medical (Singapore) Pte, Ltd.'s cleared 510(k)s is 162 days. Since 2017: 192 days, versus 238 days for all cleared 510(k)s in the same product codes.
What devices does Venner Medical (Singapore) Pte, Ltd. make?
Its most frequent FDA product codes are BTO (Tube, Tracheostomy (W/Wo Connector), 2); BTR (Tube, Tracheal (W/Wo Connector), 2); BSK (Cuff, Tracheal Tube, Inflatable, 1).
Has Venner Medical (Singapore) Pte, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Venner Medical (Singapore) Pte, Ltd. Related entities may recall under other names.
Next steps
- See all 6 Venner Medical (Singapore) Pte, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BTO, Venner Medical (Singapore) Pte, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.