Visionsense, Ltd.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Visionsense, Ltd.” (first 2008, latest 2022), across 6 product codes in 5 review panels. Median 510(k) review time under this name: 83 days. Since 2017 the median was 286 days, against 105 days for all cleared 510(k)s in the same product codes. 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 | 2 | 110 |
| 2014 | 1 | 69 |
| 2015 | 2 | 123 |
| 2016 | 1 | 73 |
| 2017 | 0 | — |
| 2018 | 1 | 286 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 294 |
| 2022 | 1 | 29 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Visionsense, Ltd. took a median 286 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OWN | Confocal Optical Imaging | 4 | 4 |
| HRX | Arthroscope | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| GWG | Endoscope, Neurological | 2 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 | 1 |
Review panels
- General and Plastic Surgery (6)
- Orthopedic (3)
- Neurology (2)
- Ear, Nose and Throat (1)
- Gastroenterology and Urology (1)
Most recent Visionsense, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223020 | VS3-Iridium System (VS3-IR) | OWN | 2022-10-28 | 29 |
| K210265 | VS3 Iridium Sytem | OWN | 2021-11-22 | 294 |
| K171208 | Trans-anal Introducer | FED | 2018-02-05 | 286 |
| K153548 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | HRX | 2016-02-22 | 73 |
| K152204 | VS3-IR system | OWN | 2015-10-28 | 83 |
| K150018 | VS3-IR-MMS System | OWN | 2015-06-17 | 163 |
| K141002 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | HRX | 2014-06-26 | 69 |
| K131434 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | GWG | 2013-07-16 | 60 |
| K123467 | VS3 | GCJ | 2013-04-17 | 159 |
| K082355 | VISIONSENSE STEREOSCOPIC VISION SYSTEM | HRX | 2008-12-15 | 122 |
3 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 2 recall events; 3 initiated in the last five years. Most recent: 2022-10-17.
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 Visionsense, Ltd.?
FDA lists 13 510(k) clearances under the applicant name “Visionsense, Ltd.” (first 2008, latest 2022), across 6 product codes in 5 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 Visionsense, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Visionsense, Ltd. is 83 days. Since 2017: 286 days, versus 105 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Visionsense, Ltd.?
The most frequent FDA product codes under this applicant name are OWN (Confocal Optical Imaging, 4); HRX (Arthroscope, 3); GCJ (Laparoscope, General & Plastic Surgery, 2).
Next steps
- See all 13 Visionsense, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OWN, Visionsense, Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.