# Oridion Capnography, Inc.

- Location (FDA's records): Jerusalem, IL
- FDA decisions: 5 (2006–2011): 5 510(k) clearances
- Product codes: DQA (4), CCK (1)
- Predicates its devices cite: 11 (4 its own); citations of its devices by later devices: 22 (4 its own)
- Recalls linked to its devices: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nellcor Puritan Bennett, Inc.: 2 (https://510kreport.com/company/nellcor-puritan-bennett)
- Oridion, Ltd.: 1 (https://510kreport.com/company/oridion)
- Cas Medical Systems, Inc.: 1 (https://510kreport.com/company/cas-medical-systems)
- Larsen & Toubro Limited: 1 (https://510kreport.com/company/larsen-toubro)
- Welch Allyn, Inc.: 1 (https://510kreport.com/company/welch-allyn)
- Masimo Corporation: 1 (https://510kreport.com/company/masimo)

## Firms that cite its devices most
- Philips Medical Systems, Inc.: 3 (https://510kreport.com/company/philips-medical-systems)
- Zoll Medical Corporation, World Wide Headquarters: 2 (https://510kreport.com/company/zoll-medical-world-wide-headquarters)
- Edan Instruments, Inc.: 1 (https://510kreport.com/company/edan-instruments)
- Spacelabs Healthcare Medical Equipment (Suzhou) CO: 1 (https://510kreport.com/company/spacelabs-healthcare-medical-equipment-suzhou)
- Medipines Corporation: 1 (https://510kreport.com/company/medipines)
- Oridion Medical 1987, Ltd.: 1 (https://510kreport.com/company/oridion-medical-1987)
- Fukuda Denshi USA, Inc.: 1 (https://510kreport.com/company/fukuda-denshi-usa)
- Schiller AG: 1 (https://510kreport.com/company/schiller)

## Its most-cited devices
- K094012: CAPNOSTREAM20 with MICROMEDICO2 Module (2010), cited by 8
- K060065: CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor (2006), cited by 7
- K082268: CAPNOSTREAM20 with Integrated Pulmonary Index (2009), cited by 3
- K072295: Capnostream 20 with A2 Adaptive Averaging Software (2007), cited by 3
- K101995: Capnostream 20P with Masimo SPO2 Board (2011), cited by 1

## Recent decisions
- K101995: Capnostream 20P with Masimo SPO2 Board (Jan 11, 2011)
- K094012: CAPNOSTREAM20 with MICROMEDICO2 Module (May 12, 2010)
- K082268: CAPNOSTREAM20 with Integrated Pulmonary Index (Feb 6, 2009)
- K072295: Capnostream 20 with A2 Adaptive Averaging Software (Oct 11, 2007)
- K060065: CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor (May 4, 2006)

Source page: https://510kreport.com/company/oridion-capnography