# K211498: Nonin OTC Pulse Oximeter Model 3250

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Nov 13, 2024 after 1,279 days
- Product code: OLK (Pulse Oximeter For Over-The-Counter Use)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K962603 (1997). 112 ancestors in all.
No later device cites it as a predicate yet.
1 of 113 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214115: MightySat -OTC, Masimo Corporation (2024). Cleared while this submission was under review Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K211498
Methodology: https://510kreport.com/methodology