Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart C — Monitoring Devices](/submissions/AN/subpart-c%E2%80%94monitoring-devices) → [21 CFR 868.2350](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2350) → BXY — Flowmeter, Calibration, Gas

# BXY · Flowmeter, Calibration, Gas

_Anesthesiology · 21 CFR 868.2350 · Class 1_

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

## Overview

- **Product Code:** BXY
- **Device Name:** Flowmeter, Calibration, Gas
- **Regulation:** [21 CFR 868.2350](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2350)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A gas calibration flowmeter is a device intended for medical purposes that is used to calibrate flowmeters and accurately measure gas flow.

## 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 (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K953506](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXY/K953506.md) | WESTMED RESPIRATORY LUER ADAPTOR | Westmed Intl. | Sep 15, 1995 | SESE |
| [K902917](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXY/K902917.md) | PRECISION MEDICAL ELIMINATOR | Precision Medical, Inc. | Jul 23, 1990 | SESE |
| [K902916](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXY/K902916.md) | PRECISION MEDICAL NEB BLOCK | Precision Medical, Inc. | Jul 23, 1990 | SESE |
| [K863510](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXY/K863510.md) | OXY-OFF(TM) | B&B Medical Technologies, Inc. | Oct 22, 1986 | SESE |
| [K860516](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXY/K860516.md) | LSP MINILATOR | Life Support Products, Inc. | Feb 21, 1986 | SESE |
| [K851460](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXY/K851460.md) | NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA | Telectronics, Inc. | May 10, 1985 | SESE |
| [K781523](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXY/K781523.md) | PFT GASES | Gardner Cryogenics | Dec 1, 1978 | SESE |

## Top Applicants

- Precision Medical, Inc. — 2 clearances
- Westmed Intl. — 1 clearance
- Telectronics, Inc. — 1 clearance
- Life Support Products, Inc. — 1 clearance
- Gardner Cryogenics — 1 clearance

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

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