Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter
FDA 510(k) K162675 · Masimo Corporation
510(k) numberK162675
Submission
- Device name
- Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter
- Applicant
- Masimo Corporation
Irvine, CA, US - Received
- September 26, 2016
- Decision date
- December 28, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| 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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| K234021 | Masimo StorkQYU · Traditional | 05/03/2024SE |
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Questions and answers
When was Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter cleared by the FDA?
Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter (K162675) received a 510(k) decision of Substantially Equivalent on December 28, 2016, 93 days after the submission was received.
What is the product code of K162675?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.