# Vioptix, Inc.

- Location (FDA's records): Newark, CA
- FDA decisions: 9 (2005–2025): 9 510(k) clearances
- Product codes: MUD (8), MVR (1)
- 510(k) review time since 2016: median 124 days, against 124 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 11 (7 its own); citations of its devices by later devices: 9 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hutchinson Technology, Inc.: 3 (https://510kreport.com/company/hutchinson-technology)
- Synovis Micro Companies Alliance, Inc.: 1 (https://510kreport.com/company/synovis-micro-companies-alliance)

## Firms that cite its devices most
- Iss Medical, Inc.: 1 (https://510kreport.com/company/iss-medical)
- Mimosa Diagnostics, Inc.: 1 (https://510kreport.com/company/mimosa-diagnostics)

## Its most-cited devices
- K042657: Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2 (2005), cited by 4
- K133983: Intra. OX Handheld Tissue Oximeter (2014), cited by 1
- K233488: Intra.Ox™ 2.0 Handheld Tissue Oximeter (2024), cited by 1
- K163472: Intra.Ox Handheld Tissue Oximeter (2017), cited by 1
- K221010: Intra.Ox 2.0 Handheld Tissue Oximeter (2022), cited by 1
- K191676: Intra.Ox 2.0 Handheld Tissue Oximeter (2019), cited by 1

## Recent decisions
- K250519: Lap.Ox™ Laparoscopic Tissue Oximeter (Jun 26, 2025)
- K233488: Intra.Ox™ 2.0 Handheld Tissue Oximeter (Feb 28, 2024)
- K221010: Intra.Ox 2.0 Handheld Tissue Oximeter (May 3, 2022)
- K191676: Intra.Ox 2.0 Handheld Tissue Oximeter (Sep 16, 2019)
- K163472: Intra.Ox Handheld Tissue Oximeter (Nov 16, 2017)
- K133983: Intra. OX Handheld Tissue Oximeter (Sep 12, 2014)
- K141234: Odissey Tissue Oximeter (Jul 1, 2014)
- K090679: Vesselink Microvascular Anastomotic Coupler System (Apr 17, 2009)

Source page: https://510kreport.com/company/vioptix