Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1170](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1170) → CBZ — Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling

# CBZ · Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling

_Anesthesiology · 21 CFR 868.1170 · Class 2_

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

## Overview

- **Product Code:** CBZ
- **Device Name:** Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
- **Regulation:** [21 CFR 868.1170](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1170)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **3rd-party reviewable:** yes

## Identification

An indwelling blood hydrogen ion concentration (pH) analyzer is a device that consists of a catheter-tip pH electrode and that is used to measure, in vivo, the hydrogen ion concentration (pH) in blood to aid in determining the patient's acid-base balance.

## Classification Rationale

Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”

## Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K020967](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBZ/K020967.md) | TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM | Terumo Cardiovascular Systems Corp. | Jun 20, 2002 | SESE |
| [K970906](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBZ/K970906.md) | PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR | Diametrics Medical, Ltd. | Sep 23, 1997 | SESE |
| [K931112](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBZ/K931112.md) | MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI | Puritan Bennett Corp. | Jun 1, 1993 | SESE |
| [K920061](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBZ/K920061.md) | HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM | Abbott Laboratories | Mar 30, 1992 | SESE |
| [K912030](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBZ/K912030.md) | CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED | 3M Company | Oct 30, 1991 | SESE |
| [K912428](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBZ/K912428.md) | PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT | Puritan Bennett Corp. | Aug 9, 1991 | SESE |
| [K884228](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBZ/K884228.md) | CDI(R) 2000 BLOOD GAS MONITOR | Cardiovascular Devices, Inc. | Jan 30, 1989 | SESE |
| [K862114](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBZ/K862114.md) | KHURI REGIONAL TISSUE PH MONITOR | Vascular Technology Incorporated | Jun 25, 1986 | SESE |
| [K803260](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBZ/K803260.md) | SENSOMAT MUSCLE/TISSUE PH | Biochem International, Inc. | Feb 2, 1981 | SESE |
| [K803014](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBZ/K803014.md) | SENSOMAT | Biochem International, Inc. | Dec 22, 1980 | SESE |

## Top Applicants

- Puritan Bennett Corp. — 2 clearances
- Biochem International, Inc. — 2 clearances
- Vascular Technology Incorporated — 1 clearance
- Terumo Cardiovascular Systems Corp. — 1 clearance
- Diametrics Medical, Ltd. — 1 clearance

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

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