Vioptix, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Vioptix, Inc.” (first 2005, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 104 days. Since 2017 the median was 124 days, against 130 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 | 0 | — |
| 2014 | 2 | 154 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 339 |
| 2018 | 0 | — |
| 2019 | 1 | 84 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 28 |
| 2023 | 0 | — |
| 2024 | 1 | 124 |
| 2025 | 1 | 125 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vioptix, Inc. took a median 124 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 130 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MUD | Oximeter, Tissue Saturation | 8 | 8 |
| MVR | Device, Anastomotic, Microvascular | 1 | 1 |
Review panels
Most recent Vioptix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250519 | Lap.Ox Laparoscopic Tissue Oximeter | MUD | 2025-06-26 | 125 |
| K233488 | Intra.Ox 2.0 Handheld Tissue Oximeter | MUD | 2024-02-28 | 124 |
| K221010 | Intra.Ox 2.0 Handheld Tissue Oximeter | MUD | 2022-05-03 | 28 |
| K191676 | Intra.Ox 2.0 Handheld Tissue Oximeter | MUD | 2019-09-16 | 84 |
| K163472 | Intra.Ox Handheld Tissue Oximeter | MUD | 2017-11-16 | 339 |
| K133983 | INTRA. OX HANDHELD TISSUE OXIMETER | MUD | 2014-09-12 | 259 |
| K141234 | ODISSEY TISSUE OXIMETER | MUD | 2014-07-01 | 49 |
| K090679 | VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM | MVR | 2009-04-17 | 32 |
| K042657 | VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 | MUD | 2005-01-10 | 104 |
Recalls
openFDA lists no recalls under a recalling firm named Vioptix, Inc..
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 Vioptix, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Vioptix, Inc.” (first 2005, latest 2025), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vioptix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vioptix, Inc. is 104 days. Since 2017: 124 days, versus 130 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Vioptix, Inc.?
The most frequent FDA product codes under this applicant name are MUD (Oximeter, Tissue Saturation, 8); MVR (Device, Anastomotic, Microvascular, 1).
Next steps
- See all 9 Vioptix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MUD, Vioptix, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.