Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Visionsense, Ltd. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
286 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223020 | VS3-Iridium System (VS3-IR) | Visionsense, Ltd. | 2022-10-28 | 29 | 0 |
| K210265 | VS3 Iridium Sytem | Visionsense, Ltd. | 2021-11-22 | 294 | 0 |
| K171208 | Trans-anal Introducer | Visionsense, Ltd. | 2018-02-05 | 286 | 0 |
| K153548 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | Visionsense, Ltd. | 2016-02-22 | 73 | 0 |
| K152204 | VS3-IR system | Visionsense, Ltd. | 2015-10-28 | 83 | 0 |
| K150018 | VS3-IR-MMS System | Visionsense, Ltd. | 2015-06-17 | 163 | 3 |
| K141002 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | Visionsense, Ltd. | 2014-06-26 | 69 | 0 |
| K131434 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | Visionsense, Ltd. | 2013-07-16 | 60 | 0 |
| K123467 | VS3 | Visionsense, Ltd. | 2013-04-17 | 159 | 0 |
| K082355 | VISIONSENSE STEREOSCOPIC VISION SYSTEM | Visionsense, Ltd. | 2008-12-15 | 122 | 0 |
| K082667 | VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) | Visionsense, Ltd. | 2008-10-30 | 48 | 0 |
| K081102 | VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM | Visionsense, Ltd. | 2008-05-29 | 42 | 1 |
| K073279 | VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM | Visionsense, Ltd. | 2008-03-05 | 105 | 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