21 CFR § 868.2480 - Cutaneous carbon dioxide (PcCO2) monitor.

---
identifier: "/us/cfr/t21/s868.2480"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 868.2480 - Cutaneous carbon dioxide (PcCO2) monitor."
title_number: 21
title_name: "Food and Drugs"
section_number: "868.2480"
section_name: "Cutaneous carbon dioxide (PcCO2) monitor."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "868"
part_name: "ANESTHESIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "47 FR 31142, July 16, 1982, unless otherwise noted."
cfr_part: "868"
---


# 868.2480 Cutaneous carbon dioxide (PcCO2) monitor.

(a) *Identification.* A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive heated sensor and a pH-sensitive glass electrode placed on a patient's skin, which is intended to monitor relative changes in a hemodynamically stable patient's cutaneous carbon dioxide tension as an adjunct to arterial carbon dioxide tension measurement.

(b) *Classification.* Class II (special controls). The special control for this device 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.

[54 FR 27160, June 28, 1989, as amended at 67 FR 76681, Dec. 13, 2002]