# K060065: CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Oridion Capnography, Inc.
- Decided: May 4, 2006 after 115 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962603 (1997). 34 ancestors in all.
250 later devices descend from it; 7 cite it directly.
2 of 285 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040011: Polaris 2004 Capnograph, Oridion, Ltd. (2004) Summary page 2.
- K050844: 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL, Cas Medical Systems, Inc. (2005) Summary page 2.
- K051608: Star 50 Monitoring System, Larsen & Toubro Limited (2005) Summary page 2.
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories), Nellcor Puritan Bennett, Inc. (2002) Summary page 2.
- K021090: Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter, Nellcor Puritan Bennett, Inc. (2002) Summary page 2.
- K022084: Atlas Monitor, Models 200,210,220, Welch Allyn, Inc. (2002) Summary page 2.

## Most influential descendants
- K072295: Capnostream 20 with A2 Adaptive Averaging Software (2007), 197 descendants of its own
- K082268: CAPNOSTREAM20 with Integrated Pulmonary Index (2009), 170 descendants of its own
- K091241: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter (2009), 155 descendants of its own
- K100428: Masimo Rainbow Set Radical 7R Pulse CO-Oximeter (2010), 115 descendants of its own
- K094012: CAPNOSTREAM20 with MICROMEDICO2 Module (2010), 93 descendants of its own

## Recalls of this device
- Jun 30, 2009 · Not classified · Z-2232-2009: 1) The monitor's ability to withstand electrostatic discharge (ESD) to exposed metal connectors on the back of the monitor which may cause the monitor's display to freeze. 2) The unit generates electr
- Jul 28, 2007 · Not classified · Z-0177-2008: Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall.
- Jul 28, 2007 · Not classified · Z-0178-2008: Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall.

## Indications for use
The Capnostream 2 0 is intended for CO 2 and SPO2 indications. The Capnostream 20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2 and pulse rate). It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments. The Capnostreamlo is intended for C02 indications only. The Capnostream1 0 is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath. It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments.

Source page: https://510kreport.com/device/K060065
Methodology: https://510kreport.com/methodology