Intra.Ox 2.0 Handheld Tissue Oximeter
FDA 510(k) K191676 · Vioptix, Inc.
510(k) numberK191676
Submission
- Device name
- Intra.Ox 2.0 Handheld Tissue Oximeter
- Applicant
- Vioptix, Inc.
Newark, CA, US - Received
- June 24, 2019
- Decision date
- September 16, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MUD – Oximeter, Tissue Saturation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
Other 510(k)s with product code MUD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254129 | Spectrum-2MUD · Traditional | Neko Health AB | 05/22/2026SE |
| K243324 | Masimo O3 Regional OximeterMUD · Traditional | Masimo Corporation | 07/17/2025SE |
| K250519 | Lap.Ox Laparoscopic Tissue OximeterMUD · Traditional | ViOptix, Inc. | 06/26/2025SE |
| K240596 | Cerebral Autoregulation Index (CAI) AlgorithmMUD · Traditional | Edwards Lifesciences | 10/16/2024SE |
| K241393 | ODI-TechMUD · Traditional | Odi Medical AS | 08/30/2024SE |
| K240601 | SnapshotNIR model KD205MUD · Traditional | Kent Imaging, Inc. | 04/02/2024SE |
| K232385 | OxiplexTS200MUD · Traditional | Iss Medical, Inc. | 03/01/2024SE |
| K233488 | Intra.Ox 2.0 Handheld Tissue OximeterMUD · Traditional | Vioptix, Inc. | 02/28/2024SE |
| K230612 | Edwards Algorithm for Measurement of Blood HemoglobinMUD · Traditional | Edwards Lifesciences, LLC | 11/17/2023SE |
| K223651 | Cerebral Adaptive Index (CAI) AlgorithmMUD · Traditional | Edwards Lifesciences, LLC | 05/26/2023SE |
More from Edwards Lifesciences, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K250519 | Lap.Ox Laparoscopic Tissue OximeterMUD · Traditional | 06/26/2025SE |
| K233488 | Intra.Ox 2.0 Handheld Tissue OximeterMUD · Traditional | 02/28/2024SE |
| K221010 | Intra.Ox 2.0 Handheld Tissue OximeterMUD · Special | 05/03/2022SE |
| K163472 | Intra.Ox Handheld Tissue OximeterMUD · Traditional | 11/16/2017SE |
| K133983 | Intra. Ox Handheld Tissue OximeterMUD · Traditional | 09/12/2014SE |
| K141234 | Odissey Tissue OximeterMUD · Traditional | 07/01/2014SE |
| K090679 | Vesselink Microvascular Anastomotic Coupler SystemMVR · Traditional | 04/17/2009SE |
| K042657 | Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model OXY-2MUD · Traditional | 01/10/2005SE |
Questions and answers
When was Intra.Ox 2.0 Handheld Tissue Oximeter cleared by the FDA?
Intra.Ox 2.0 Handheld Tissue Oximeter (K191676) received a 510(k) decision of Substantially Equivalent on September 16, 2019, 84 days after the submission was received.
What is the product code of K191676?
The FDA product code is MUD – Oximeter, Tissue Saturation, a Class II (moderate risk) device regulated under 21 CFR 870.2700.