Oridion Capnography, Inc.
Country not established
- Devices
- 5
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Oridion Capnography, Inc. makes
Oridion Capnography, Inc. manufactures bedside capnography monitors, including multi-parameter devices like the Capnostream20 with integrated pulmonary index and adaptive averaging software. Their portfolio includes single-parameter models (Capnostream10) and modular systems, such as the Capnostream20 with add-on modules for oxygen saturation (Masimo SpO₂) and CO₂ measurement (Micromedico₂). These devices are designed for real-time respiratory monitoring in clinical settings.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. Their products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
CAPNOSTREAM20 With Integrated Pulmonary Index Ref K082268
Regimes: 510(k) Registry: 510(k)CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor Ref K060065
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
CAPNOSTREAM20 With MICROMEDICO2 Module Ref K094012
Regimes: 510(k) Registry: 510(k)Capnostream 20P With Masimo SPO2 Board Ref K101995
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Oridion Capnography, Inc., initiated on 2007-07-28. By recorded status: 2 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 28 Jul 2007 Z-0177-2008 Unclassified (pre-2012) Terminated Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall.
- 28 Jul 2007 Z-0178-2008 Unclassified (pre-2012) Terminated Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall.
Frequently asked questions
How many devices does Oridion Capnography, Inc. have in the registry?
The registry currently lists 5 devices for Oridion Capnography, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oridion Capnography, Inc.'s devices?
Among its 5 most recently registered devices, Oridion Capnography, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Oridion Capnography, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Oridion Capnography, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Oridion Capnography, Inc.?
FDA recall records list 2 recalls initiated by Oridion Capnography, Inc., the most recent initiated on 28 Jul 2007. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Oridion Capnography, Inc. in the registry?
The most recently registered devices listed for Oridion Capnography, Inc. include CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX, CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR, CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE and CAPNOSTREAM20 WITH MICROMEDICO2 MODULE.