Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2710](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2710) → DPZ — Oximeter, Ear

# DPZ · Oximeter, Ear

_Cardiovascular · 21 CFR 870.2710 · Class 2_

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

## Overview

- **Product Code:** DPZ
- **Device Name:** Oximeter, Ear
- **Regulation:** [21 CFR 870.2710](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2710)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K042675](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ/K042675.md) | FLEXI-STAT SP02 EAR SENSOR | Elekon Industries U.S.A., Inc. | Dec 6, 2004 | SESE |
| [K040831](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ/K040831.md) | DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 | Datex-Ohmeda, Inc. | Sep 2, 2004 | SESE |
| [K012333](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ/K012333.md) | FLEXI-SITE SP02 EAR SENSOR | Epic Medical Equipment Services, Inc. | Oct 17, 2001 | SESE |
| [K010718](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ/K010718.md) | FLEXI-SITE SP02 EAR SENSOR | Epic Medical Equipment Services, Inc. | Mar 23, 2001 | SESE |
| [K944760](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ/K944760.md) | DURA-Y OXYGEN TRANSDUCER, EAR CLIP | Nellcor, Inc. | Oct 17, 1994 | SESE |
| [K942752](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ/K942752.md) | MARQUETTE EAR PROBE SENSOR | Marquette Electronics, Inc. | Sep 2, 1994 | SESE |
| [K914595](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ/K914595.md) | PULSE RATE MONITOR | Fitness Quest, Inc. | Jan 31, 1992 | SESE |
| [K862426](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ/K862426.md) | PULSE OXIMETER | Draeger Medical, Inc. | Sep 11, 1986 | SESE |
| [K845051](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ/K845051.md) | VITALOG PMS-8 | Vitalog Corp. | May 15, 1985 | SESE |
| [K850494](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ/K850494.md) | OHMEDA BIOX 3700 PULSE OXIMETER | Ohmeda Medical | Mar 28, 1985 | SESE |
| [K810363](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ/K810363.md) | EAR OXIMETER | Bio-Tek Instruments, Inc. | Feb 27, 1981 | SESE |

## Top Applicants

- Epic Medical Equipment Services, Inc. — 2 clearances
- Bio-Tek Instruments, Inc. — 1 clearance
- Datex-Ohmeda, Inc. — 1 clearance
- Draeger Medical, Inc. — 1 clearance
- Elekon Industries U.S.A., Inc. — 1 clearance

---

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

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