Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Venner Medical (Singapore) Pte, Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
179 daysmedian FDA review time
314 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192511 | Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner Pne | Venner Medical (Singapore) Pte, Ltd. | 2020-07-22 | 314 | 0 |
| K192120 | Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ET | Venner Medical (Singapore) Pte, Ltd. | 2020-02-14 | 192 | 0 |
| K191602 | APA Oxy Blade | Venner Medical (Singapore) Pte, Ltd. | 2019-08-02 | 46 | 0 |
| K110631 | VENNER TRACHEAL SEAL MONITOR | Venner Medical (Singapore) Pte, Ltd. | 2011-07-28 | 146 | 0 |
| K100950 | VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE | Venner Medical (Singapore) Pte, Ltd. | 2010-07-13 | 98 | 0 |
| K093135 | VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL T | Venner Medical (Singapore) Pte, Ltd. | 2010-04-02 | 179 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda