Odissey Tissue Oximeter
510(k) K141234
Odissey Tissue Oximeter is a Class II device made by Vioptix, Inc., cleared under FDA 510(k) K141234 on 1 Jul 2014, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK141234 | Date1 Jul 2014 | StatusActive |
Official records
- FDA 510(k) database K141234
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MUD
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2700
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K141234
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| T.Ox SP Sensor OXY-2-SPD-1 | OXY-2-SPD-1 / OXY-2-SPD-1 | B426OXY2SPD10 | — | On the market |
| T.Ox SS Sensor OXY2-SPI-1 | OXY-2-SPI-1 / OXY2-SPI-1 | B426OXY2SPI10 | — | On the market |
Similar devices
Other devices filed under FDA product code MUD (Oximeter, Tissue Saturation).
- ForeSight FSESNS by Edwards Lifesciences LLC
- OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S by Somanetics Corp.
- T-Stat 2.0 Microvascular Tissue Oximeter by Spectros Corporation
- MIMOSA Imager by Mimosa Diagnostics, Inc.
- INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) by Covidien llc
- FORE-SIGHT Elite Absolute Tissue Oximeter by CAS MEDICAL SYSTEMS, INC.
- BIOSPECTROMETER-NB OXIMETER IIII by Hutchinson Technology, Inc.
- OxiplexTS200 by Iss Medical, Inc.
- ODI-Tech by Odi Medical AS
- ForeSight IQ FSESLIQ by Edwards Lifesciences LLC