CCL · Analyzer, Gas, Oxygen, Gaseous-Phase
Anesthesiology · 21 CFR 868.1720 · Class 2
Overview
| Product Code | CCL |
|---|---|
| Device Name | Analyzer, Gas, Oxygen, Gaseous-Phase |
| Regulation | 21 CFR 868.1720 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 121)
Showing 20 most recent of 121 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251245 | OxyMinder Pro (10310) | Bio-Med Device, Inc. | Aug 11, 2025 | SESE |
| K250002 | Smart Check O2 (MA0236) | Life Spark Medical, LLC | Apr 24, 2025 | SESE |
| K221734 | Maxtec MaxO2 ME+p | Maxtec, LLC | Apr 1, 2023 | SESE |
| K213933 | Percent Oxygen Sensors | Careox, LLC | Aug 19, 2022 | SESE |
| K213948 | OxyMinder | Bio-Med Devices, Inc. | Mar 17, 2022 | SESE |
| K173807 | Accu O2 Oxygen Analyzer | Precision Medical, Inc. | May 2, 2018 | SESE |
| K153659 | MaxO2ME | Maxtec, LLC | Jun 10, 2016 | SESE |
| K123195 | CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES | GE Healthcare Finland Oy | Feb 28, 2013 | SESE |
| K122290 | ENVITEC MYSIGN O OXYGEN MEASURING DEVICE | Envitec-Wismar GmbH | Jan 23, 2013 | SESE |
| K112402 | ULTRAMAXO2 OXYGEN ANALYER | Maxtec, LLC | Dec 14, 2011 | SESE |
| K082655 | ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 | Envitec-Wismar GmbH | Nov 25, 2008 | SESE |
| K072469 | DIGIFLO CONCENTRATOR ANALYZER | Digiflo, Inc. | Jan 3, 2008 | SESE |
| K063096 | PRECISION OXYGEN MONITOR | Precision Medical, Inc. | Feb 27, 2007 | SESE |
| K063488 | MAXO2 CU | Maxtec, Inc. | Feb 22, 2007 | SESE |
| K053407 | OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M | Analytical Industries, Inc. | Apr 5, 2006 | SESE |
| K051092 | DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC | GE Healthcare | May 25, 2005 | SESE |
| K041773 | OXYGEN MEDICELS, CITICELS | City Technology Limited | Jul 15, 2004 | SESE |
| K040484 | MAXO2+, MODEL A AND AE | Maxtec, Inc. | Jun 9, 2004 | SESE |
| K024228 | RX300 OXYGEN ANALYZER | Teledyne Analytical Instruments | Jul 17, 2003 | SESE |
| K024155 | MX 300 OXYGEN MONITOR | Teledyne Analytical Instruments | Jul 17, 2003 | SESE |
Top Applicants
- Catalyst Research Corp. — 4 clearances
- Ceramatec, Inc. — 4 clearances
- Salter Labs — 4 clearances
- Vascular Technology Incorporated — 4 clearances
- Analytical Industries, Inc. — 3 clearances
