MightySat -OTC
FDA 510(k) K214115 · Masimo Corporation
510(k) numberK214115
Submission
- Device name
- MightySat -OTC
- Applicant
- Masimo Corporation
Irvine, CA, US - Received
- December 30, 2021
- Decision date
- January 31, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLK – Pulse Oximeter For Over-The-Counter Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring
Other 510(k)s with product code OLK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K211498 | Nonin OTC Pulse Oximeter Model 3250OLK · Traditional | Nonin Medical, Inc. | 11/13/2024SE |
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| K250757 | Radius VSM and AccessoriesMHX · Traditional | 05/29/2025SE |
| K243305 | Masimo W1DPS · Traditional | 04/03/2025SE |
| K240229 | Masimo W1DPS · Traditional | 08/08/2024SE |
| K234021 | Masimo StorkQYU · Traditional | 05/03/2024SE |
| K223721 | Masimo StorkDQA · Traditional | 12/15/2023SE |
| K232512 | Masimo W1DPS · Traditional | 11/17/2023SE |
Questions and answers
When was MightySat -OTC cleared by the FDA?
MightySat -OTC (K214115) received a 510(k) decision of Substantially Equivalent on January 31, 2024, 762 days after the submission was received.
What is the product code of K214115?
The FDA product code is OLK – Pulse Oximeter For Over-The-Counter Use, a Class II (moderate risk) device regulated under 21 CFR 870.2700.