FDA 510(k) · Nonin Medical
K211498: Nonin OTC Pulse Oximeter Model 3250 (Nonin Medical, Inc.)
Nonin Medical, Inc. received FDA 510(k) K211498 for Nonin OTC Pulse Oximeter Model 3250, with a decision date of Nov 13, 2024 (substantially equivalent).
Prescription or OTC: Prescription (Rx) parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K211498 |
|---|---|
| Pathway | 510(k) |
| Applicant | Nonin Medical, Inc. |
| Device name | Nonin OTC Pulse Oximeter Model 3250 |
| Product code | OLK: Pulse Oximeter For Over-The-Counter Use |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | May 14, 2021 |
| Decision date | Nov 13, 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 Nonin Medical 3250 Finger Pulse Oximeter is a small, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of individuals who are well or poorly perfused under no motion conditions for medical use without a prescription. It is intended for spot-checking of individuals 18 years and older with finger thickness between 0.8-2.5 cm (0.3-1.0 inch). It is not intended for the diagnosis or screening of lung disease, for use in treatment decisions, and should only be used for making healthcare decisions 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.
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.