Data / Medical devices / Analyzer, Gas, Oxygen, Gaseous-Phase
Analyzer, Gas, Oxygen, Gaseous-Phase (CCL): 64 FDA-registered makers in 14 countries
64 establishments in 14 countries are registered with the FDA to make Analyzer, Gas, Oxygen, Gaseous-Phase (product code CCL, Class 2, 21 CFR 868.1720). 20 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 122 510(k) clearances under this code, the latest on July 30, 2026, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CCL
- Device class
- 2
- Regulation
- 868.1720
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 29 |
| China | 7 |
| Germany | 6 |
| Mexico | 4 |
| Finland | 3 |
| United Kingdom | 3 |
| Japan | 3 |
| Estonia | 2 |
| India | 2 |
| Singapore | 1 |
| France | 1 |
| Poland | 1 |
| Malaysia | 1 |
| Taiwan | 1 |
Makers of Analyzer, Gas, Oxygen, Gaseous-Phase
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Salaera, LLC d.b.a Maxtec | Salt Lake City, UT, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | 11 | April 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Analytical Industries, Inc. | Middleton, WI, United States | Manufacturer | 3 | April 5, 2006 | 0 | 0 | 0 | api.fda.gov |
| Honeywell Healthcare Solutions GmbH (formerly EnviteC) | WISMAR Mecklenburg-Western Pomerania, Germany | Contract manufacturer, Manufacturer, Specification developer | 3 | January 23, 2013 | 0 | 0 | 0 | api.fda.gov |
| Precision Medical, Inc. | Northampton, PA, United States | Manufacturer | 2 | May 2, 2018 | 0 | 0 | 0 | api.fda.gov |
| Aei Technologies Inc. | Bastrop, TX, United States | Manufacturer | 1 | November 1, 1996 | 0 | 0 | 0 | api.fda.gov |
| AirLife Finland Oy | Helsinki Uusimaa, Finland | Complaint file establishment, Specification developer | 1 | July 30, 2026 | 0 | 0 | 0 | api.fda.gov |
| Bio-Med Devices, Inc. | Guilford, CT, United States | Manufacturer | 1 | March 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| Draeger Medical Systems, Inc. | Andover, MA, United States | Manufacturer | 1 | November 3, 1999 | 0 | 0 | 0 | api.fda.gov |
| DRW Medical | Aston, PA, United States | Manufacturer | 1 | February 27, 2007 | 0 | 0 | 0 | api.fda.gov |
| Ge Healthcare Finland OY | HELSINKI Uusimaa, Finland | Manufacturer, Specification developer | 1 | May 25, 2005 | 0 | 0 | 0 | api.fda.gov |
| It DR. Gambert GMBH | WISMAR Mecklenburg-Western Pomerania, Germany | Manufacturer | 1 | December 15, 2000 | 0 | 0 | 0 | api.fda.gov |
| Jaeger Medical GmbH | HOECHBERG Bavaria, Germany | Complaint file establishment, Manufacturer | 1 | October 12, 1984 | 0 | 0 | 0 | api.fda.gov |
| Life Spark Medical | Hurricane, UT, United States | Manufacturer, Specification developer | 1 | April 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| Platinum Focus Group Ltd. | London London, City of, United Kingdom | Exporter to the US, Manufacturer | 1 | May 25, 2005 | 0 | 0 | 0 | api.fda.gov |
| Salter Labs | El Paso, TX, United States | Manufacturer | 1 | July 30, 2026 | 0 | 0 | 0 | api.fda.gov |
| Salter Labs de Mexico de S.A. de C.V. | Chihuahua Mexico, Mexico | Manufacturer | 1 | March 17, 1999 | 0 | 0 | 0 | api.fda.gov |
| Teledyne Analytical Instruments | City Industry, CA, United States | Manufacturer | 1 | June 30, 2000 | 0 | 1 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | April 2, 1984 | 0 | 1 | 0 | api.fda.gov |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Manufacturer | 1 | April 2, 1984 | 0 | 0 | 0 | api.fda.gov |
| Vacumed, Div. Of Vacumetrics, Inc. | Ventura, CA, United States | Manufacturer | 1 | May 26, 1998 | 0 | 0 | 0 | api.fda.gov |
| Advanced Instrumentations, Inc. | Miami, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Airgas Therapeutics LLC | Plumsteadville, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bluepoint Medical GMBH & Co. KG | Selmsdorf Mecklenburg-Western Pomerania, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Caf Medical Solutions Inc | Hockley, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| City Technology Limited | PORTSMOUTH Hampshire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digicare Biomedical Technology, Inc. | Boynton Beach, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EDAN Diagnostics, Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics Manufacturing (Singapore) Pte Ltd | SINGAPORE South East, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems (china) Co., Ltd. | WUXI Jiangsu, China | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems Information Technologies | El Paso, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. | JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Waukesha, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Wauwatosa, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Biolight Meditech Co., Ltd | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hosmed Inc. | Doral, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inosystems | ANTONY Hauts-de-Seine, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrial Vallera de Mexicali, S. A. de C. V. | Mexicali Mexico, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innokas Medical Estonia Ou | Tallinn Harjumaa, Estonia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KB Components Finland Oy | Nurmijarvi Etela-Karjala, Finland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Electronics Poland Sp.z o.o | Tarnowo Podgorne Wielkopolskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Masimo Corporation | Irvine, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medipines Corporation | Yorba Linda, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MINDRAY DS USA, Inc. | Mahwah, NJ, United States | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Masimo Medical Technologies (Malaysia) SDN BHD | Pasir Gudang Johor, Malaysia | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden Corp. | SHINJUKU-KU Tokyo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Noxbox Limited | Sittingbourne Kent, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center | Tokorozawa Saitama, Japan | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden Tomioka Corporation | Gunma Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulsion Medical Systems Se | Aschheim, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medizin Systeme Boeblingen GmbH | BOEBLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Murrysville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Export, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RAUMEDIC Estonia AS | Tallinn Harjumaa, Estonia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Respironics Novametrix, LLC | Andover, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Repair Operations Center | Oak Creek, WI, United States | Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Skanray Technologies Limited | Mysore Karnataka, India | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | SHENZHEN Guangdong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spacelabs Healthcare Inc. | Snoqualmie, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technical Services for Electronics, Inc. | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wipro Ge Medical Device Manufacturing Private Limited | Bangalore Karnataka, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.