Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Etview , Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
126 daysmedian FDA review time
182 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181880 | VivaSight-SL (TVT) system | Etview , Ltd. | 2018-11-29 | 139 | 0 |
| K181886 | VivaSight-DL System | Etview , Ltd. | 2018-11-14 | 124 | 0 |
| K152438 | ETView VivaSight-SL (TVT) system | Etview , Ltd. | 2016-02-25 | 182 | 0 |
| K123853 | VIVASIGHT-DL SYSTEM | Etview , Ltd. | 2013-04-15 | 122 | 0 |
| K121028 | ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)) | Etview , Ltd. | 2012-06-21 | 77 | 0 |
| K120334 | VIVA EB | Etview , Ltd. | 2012-06-08 | 126 | 0 |
| K113576 | DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM | Etview , Ltd. | 2012-05-18 | 165 | 0 |
| K052233 | TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM | Etview , Ltd. | 2005-12-13 | 118 | 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