Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5240](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5240) → OFP — Anesthesia Breathing Circuit Kit (Adult & Pediatric)

# OFP · Anesthesia Breathing Circuit Kit (Adult & Pediatric)

_Anesthesiology · 21 CFR 868.5240 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/OFP

## Overview

- **Product Code:** OFP
- **Device Name:** Anesthesia Breathing Circuit Kit (Adult & Pediatric)
- **Regulation:** [21 CFR 868.5240](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5240)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

## Classification Rationale

Class I (general 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.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/OFP](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/OFP)

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