FDA 510(k) · Masimo
K214115: MightySat -OTC (Masimo Corporation)
Masimo Corporation received FDA 510(k) K214115 for MightySat -OTC, with a decision date of Jan 31, 2024 (substantially equivalent).
Prescription or OTC: OTC parsed from FDA documents (derived: product code name)
FDA facts
| FDA number | K214115 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | MightySat -OTC |
| Product code | OLK: Pulse Oximeter For Over-The-Counter Use |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Dec 30, 2021 |
| Decision date | Jan 31, 2024 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Masimo MightySat-OTC is intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo MightySat-OTC is indicated for use with individuals 18 years and older who are well or poorly perfused under no motion conditions. The Masimo MightySat-OTC is not intended for diagnosis or screening of lung disease and treatment decisions using the device should only be under the advice of a healthcare provider.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- K181956 Masimo MightySat Rx Fingertip Pulse Oxi… (Masimo)
Later records that cite K214115
- K211498 Nonin OTC Pulse Oximeter Model 3250 (Nonin Medical, Nov 13, 2024, OLK)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code OLK is "Pulse Oximeter For Over-The-Counter Use", class 2, 21 CFR 870.2700. FDA's definition: "Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring"
Our labels for filtering: claim SpO2 / pulse oximetry, sensor Finger PPG. These are heuristics, not FDA fields.