Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2700](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2700) → OLK — Pulse Oximeter For Over-The-Counter Use

# OLK · Pulse Oximeter For Over-The-Counter Use

_Cardiovascular · 21 CFR 870.2700 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/OLK

## Overview

- **Product Code:** OLK
- **Device Name:** Pulse Oximeter For Over-The-Counter Use
- **Regulation:** [21 CFR 870.2700](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2700)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K211498](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/OLK/K211498.md) | Nonin OTC Pulse Oximeter Model 3250 | Nonin Medical, Inc. | Nov 13, 2024 | SESE |
| [K214115](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/OLK/K214115.md) | MightySat -OTC | Masimo Corporation | Jan 31, 2024 | SESE |

## Top Applicants

- Masimo Corporation — 1 clearance
- Nonin Medical, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/OLK](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/OLK)

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