Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables
FDA 510(k) K003167 · Masimo Corp.
510(k) numberK003167
Submission
- Device name
- Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables
- Applicant
- Masimo Corp.
Irvine, CA, US - Received
- October 10, 2000
- Decision date
- November 8, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQA – Oximeter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
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| K252655 | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO…DQA · Traditional | Shenzhen Imdk Medical Technology Co., Ltd. | 05/11/2026SE |
| K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…DQA · Traditional | Philips Medizin Systeme | 05/01/2026SE |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)DQA · Special | Unimed Medical Supplies, Inc. | 04/14/2026SE |
| K252448 | AViTA Pulse Oximeter (SP61)DQA · Traditional | Avita Corporation | 02/27/2026SE |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)DQA · Traditional | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 02/17/2026SE |
| K253109 | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)DQA · Traditional | Shenzhen Best Electronics Co., Ltd. | 01/07/2026SE |
| K251751 | Spo2 Sensor CSS032DDQA · Traditional | Shenzhen Ykd Technology Co., Ltd. | 12/19/2025SE |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…DQA · Traditional | Unimed Medical Supplies, Inc. | 12/01/2025SE |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…DQA · Traditional | Unimed Medical Supplies, Inc. | 12/01/2025SE |
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| K240229 | Masimo W1DPS · Traditional | 08/08/2024SE |
| K234021 | Masimo StorkQYU · Traditional | 05/03/2024SE |
| K214115 | MightySat -OTCOLK · Traditional | 01/31/2024SE |
| K223721 | Masimo StorkDQA · Traditional | 12/15/2023SE |
Questions and answers
When was Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables cleared by the FDA?
Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables (K003167) received a 510(k) decision of Substantially Equivalent on November 8, 2000, 29 days after the submission was received.
What is the product code of K003167?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.