Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart C — Monitoring Devices](/submissions/AN/subpart-c%E2%80%94monitoring-devices) → [21 CFR 868.2377](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2377) → NPF — Monitor, Apnea, Home Use

# NPF · Monitor, Apnea, Home Use

_Anesthesiology · 21 CFR 868.2377 · Class 2_

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

## Overview

- **Product Code:** NPF
- **Device Name:** Monitor, Apnea, Home Use
- **Regulation:** [21 CFR 868.2377](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2377)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **Life-sustaining:** yes

## Identification

An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.

## Classification Rationale

Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA.”

## Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA.”

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K061256](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/NPF/K061256.md) | SMARTMONITOR 2PS | Respironics, Inc. | Aug 2, 2006 | SESE |
| [K032403](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/NPF/K032403.md) | SMARTMONITOR 2 PROFESSIONAL SERIES (PS) | Respironics, Inc. | Oct 27, 2003 | SESE |

## Top Applicants

- Respironics, Inc. — 2 clearances

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

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