Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart C — Monitoring Devices](/submissions/AN/subpart-c%E2%80%94monitoring-devices) → [21 CFR 868.2500](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2500) → LPP — Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

# LPP · Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

_Anesthesiology · 21 CFR 868.2500 · Class 2_

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

## Overview

- **Product Code:** LPP
- **Device Name:** Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
- **Regulation:** [21 CFR 868.2500](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2500)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A cutaneous oxygen (PcO2) monitor is a noninvasive, heated sensor (e.g., a Clark-type polargraphic electrode) placed on the patient's skin that is intended to monitor relative changes in the cutaneous oxygen tension.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K001866](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LPP/K001866.md) | TCM400 | Radiometer Medical A/S | Dec 7, 2000 | SESE |
| [K885079](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LPP/K885079.md) | HORIZON 2000 TRANSCUTANEOUS GAS #26X-OPT-275 | Mennen Medical, Inc. | Feb 17, 1989 | SESE |

## Top Applicants

- Radiometer Medical A/S — 1 clearance
- Mennen Medical, Inc. — 1 clearance

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

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