Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1975](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1975) → BXA — Analyzer, Gas, Water Vapor, Gaseous-Phase

# BXA · Analyzer, Gas, Water Vapor, Gaseous-Phase

_Anesthesiology · 21 CFR 868.1975 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BXA

## Overview

- **Product Code:** BXA
- **Device Name:** Analyzer, Gas, Water Vapor, Gaseous-Phase
- **Regulation:** [21 CFR 868.1975](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1975)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A water vapor analyzer is a device intended to measure the concentration of water vapor in a patient's expired gases by using techniques such as mass spectrometry.

## 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K771510](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BXA/K771510.md) | SERVO-PAK MOLEL 0030 | Isothermal Systems, Inc. | Aug 16, 1977 | SESE |
| [K760246](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BXA/K760246.md) | ENDOTRACHEAL T CONNECTOR | Sherwood Medical Industries | Aug 4, 1976 | SESE |

## Top Applicants

- Isothermal Systems, Inc. — 1 clearance
- Sherwood Medical Industries — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BXA](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BXA)

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