Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart C — Monitoring Devices](/submissions/AN/subpart-c%E2%80%94monitoring-devices) → [21 CFR 868.2620](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2620) → BXX — Calibrator, Pressure, Gas

# BXX · Calibrator, Pressure, Gas

_Anesthesiology · 21 CFR 868.2620 · Class 1_

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

## Overview

- **Product Code:** BXX
- **Device Name:** Calibrator, Pressure, Gas
- **Regulation:** [21 CFR 868.2620](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2620)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A gas pressure calibrator is a device intended for medical purposes that is used to calibrate pressure-measuring instruments by generating a known gas pressure.

## 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 (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K923397](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXX/K923397.md) | SINGLE DOSE GAS INJECTOR | Escalon Medical Trek | Sep 14, 1992 | SESE |
| [K875075](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXX/K875075.md) | RT-200 COMPUTER INTERFACE | Timeter Instrument Corp. | Apr 21, 1988 | SESE |
| [K850029](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXX/K850029.md) | UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL | Utah Medical Products, Inc. | Apr 29, 1985 | SESE |
| [K822746](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXX/K822746.md) | RT-200 CALIBRATION ANALYZER | Timeter Instrument Corp. | Oct 13, 1982 | SESE |
| [K801258](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXX/K801258.md) | NEEDLE COUNTER-SURE COUNT/10 COUNT | Kleen Test Products | Jun 4, 1980 | SESE |
| [K801257](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXX/K801257.md) | NEEDLE COUNTER-SURE COUNT/30 CT. MAGN. | Kleen Test Products | Jun 4, 1980 | SESE |
| [K801256](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXX/K801256.md) | NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY | Kleen Test Products | Jun 4, 1980 | SESE |
| [K791294](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXX/K791294.md) | SPIROCAL | Equilibrated Bio Systems, Inc. | Aug 16, 1979 | SESE |
| [K780981](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXX/K780981.md) | PORTABLE PNEUMATIC CALIBRATOR 65-150 | Pennwalt Corp. | Aug 2, 1978 | SESE |
| [K780838](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXX/K780838.md) | PERCI | Micro Tronics Corp. | Jul 17, 1978 | SESE |

## Top Applicants

- Kleen Test Products — 3 clearances
- Timeter Instrument Corp. — 2 clearances
- Equilibrated Bio Systems, Inc. — 1 clearance
- Escalon Medical Trek — 1 clearance
- Micro Tronics Corp. — 1 clearance

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

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