Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: Is-C and Is-S
FDA 510(k) K091224 · Somanetics Corp.
510(k) numberK091224
Submission
- Device name
- Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: Is-C and Is-S
- Applicant
- Somanetics Corp.
Troy, MI, US - Received
- April 27, 2009
- Decision date
- July 9, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K093422 | Vital Sync Model 5000 SeriesMWI · Traditional | 04/29/2010SE |
| K082327 | Invos Cerebral/Somatic Oximeter System, Model: 5100CMUD · Traditional | 04/03/2009SE |
| K080769 | Invos Cerebral/Somatic Oximeter System, Model 5100CMUD · Traditional | 05/14/2008SE |
| K051274 | Invos SystemMUD · Traditional | 11/04/2005SE |
| K040162 | Correstore Patch SystemDXZ · Traditional | 03/16/2004SE |
| K031586 | Correstore Patch SystemDXZ · Traditional | 08/07/2003SE |
| K011487 | Correstore Patch, Models 1.5P2, 2P3, 3P4; Correstore Sizer, Model CRPSDXZ · Traditional | 11/21/2001SE |
| K001842 | Adult/Pediatric Cerebral Oximeter, Model Invos 5100DQA · Traditional | 09/15/2000SE |
| K971628 | Somanetics Invos 3100A Cerebral Oximeter (Invos)DQA · Traditional | 10/10/1997SE |
| K960614 | Somanetics Invos 3100A Cerebral Oximeter (Invos)DQA · Traditional | 06/05/1996SE |
Questions and answers
When was Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: Is-C and Is-S cleared by the FDA?
Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: Is-C and Is-S (K091224) received a 510(k) decision of Substantially Equivalent on July 9, 2009, 73 days after the submission was received.
What is the product code of K091224?
The FDA product code is MUD – Oximeter, Tissue Saturation, a Class II (moderate risk) device regulated under 21 CFR 870.2700.