SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)
FDA 510(k) K151305 · Nonin Medical, Inc.
510(k) numberK151305
Submission
- Device name
- SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)
- Applicant
- Nonin Medical, Inc.
Plymouth, MN, US - Received
- May 18, 2015
- Decision date
- August 27, 2015
- 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 |
|---|---|---|
| K211498 | Nonin OTC Pulse Oximeter Model 3250OLK · Traditional | 11/13/2024SE |
| K192900 | H500 Multi-Sensing Oximetry SystemDQA · Traditional | 06/29/2020SE |
| K191403 | Pulse OximeterDQA · Traditional | 12/20/2019SE |
| K190560 | SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI…MUD · Traditional | 05/02/2019SE |
| K172625 | Reusable, Finger Clip Nonin Medical CO-Met Oximetry SensorDQA · Traditional | 05/11/2018SE |
| K160231 | Model X-100C CO-Met Oximetry SystemDQA · Traditional | 12/23/2016SE |
| K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series:…DQA · Traditional | 08/05/2016SE |
| K140785 | Pulse OximeterDQA · Traditional | 07/07/2014SE |
| K132402 | Sensmart Model X-100 Univeral Oximetry SystemDQA · Traditional | 02/21/2014SE |
| K131021 | Pulse OximeterDQA · Traditional | 09/11/2013SE |
Questions and answers
When was SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg) cleared by the FDA?
SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg) (K151305) received a 510(k) decision of Substantially Equivalent on August 27, 2015, 101 days after the submission was received.
What is the product code of K151305?
The FDA product code is MUD – Oximeter, Tissue Saturation, a Class II (moderate risk) device regulated under 21 CFR 870.2700.