Capnostream20p
The FDA filing describes Capnostream20p as a combined capnograph and pulse-oximeter monitor for continuous noninvasive respiratory and oxygenation measurements. The bedside monitor contains…
The FDA filing describes Capnostream20p as a combined capnograph and pulse-oximeter monitor for continuous noninvasive respiratory and oxygenation measurements.
The bedside monitor contains a microMediCO2 capnography module and a pulse oximetry module, with display of module parameters and alarms at preset thresholds.
Listed Item
Capnostream 20P (US) W/Printer Capnograph/Pulse Oximeter
Device Description and Stated Use
The HiFi feature enables airway CO2 measurement and detects spontaneous breaths for infant and neonatal patients receiving high-frequency oscillatory ventilation. Monitoring also includes respiration rate.
29manufacturers in China registered for this device type
4catalogue numbers in this listing
17510(k) clearances naming this product code
30recalls on this code
Who Else Makes It
Concentrated in Guangdong (17), Jiangsu (5), Zhejiang (3). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Ningbo Xinwell Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 12 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Ningbo Shengyurui Medical Appliance Co. | Ningbo | Zhejiang | Contract manufacturer | 11 |
Showing 12 of 29. All 29 manufacturers in China registered for Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Record
| Listed by | Oridion Medical 1987 Ltd., Israel |
|---|---|
| FDA product code | CCK |
| Device type | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1400 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K123690 |
| Record published | 2021-08-29 |
| Record revised | 2026-02-09 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 430 to 795 Millimeter of Mercury; Handling environment humidity 10 to 95 % RH; Storage environment temperature -4 to 140 °F; Handling environment temperature 32 to 95 °F; Storage environment atmospheric pressure 57 to 106 KiloPascal; Storage environment humidity 10 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DLCS08651-03 | In distribution | |
| DLCS08657-03 | In distribution | |
| CS08657-03 | In distribution | |
| DLCS08652-03 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Salter Labs | 241 |
| Microstream | Oridion Medical 1987 Ltd. | 92 |
| Hudson RCI | Teleflex Medical LLC | 79 |
| Medline | Medline Industries, Inc. | 65 |
| BCI | ICU Medical, Inc | 64 |
| Curaplex | Bound Tree Medical, LLC | 60 |
| Microstream Advance | Oridion Medical 1987 Ltd. | 51 |
| Ventlab | Ventlab, LLC | 42 |
| Vital Signs | Carefusion Finland 320 Oy | 33 |
| AirLife™ | Airlife, Inc. | 32 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Nihon Kohden Corp. | 23 |
| Curaplex | TRI-Anim Health Services, Inc. | 23 |
Showing 12 of 441. All products under Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200594 | 2020-04-27 |
| K181624 | 2019-03-22 |
| K181467 | 2019-02-08 |
| K150272 | 2015-07-17 |
| K123690 | 2014-08-05 |
| K121927 | 2012-11-29 |
| K112368 | 2012-07-19 |
| K093388 | 2010-03-04 |
| K042665 | 2004-11-23 |
| K013845 | 2001-11-29 |
| K011536 | 2001-11-14 |
| K012391 | 2001-08-15 |
| K012394 | 2001-08-15 |
| K012395 | 2001-08-15 |
| K011050 | 2001-05-04 |
| K010024 | 2001-03-14 |
| K002163 | 2001-01-11 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2016-04-13 | Class I | Process change control | Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used with the Capnostream”20 and Capnostream”20p Patient Monitor Due to the Battery Pack Might Experience Thermal Runaway with the Potential of Fire | 9,817 batteries (8,170 with monitors and 1,647 as spare part | 2017-10-17 |
Recalls
15 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 62877 | |
| 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 5125183 | |
| 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 8435772 | |
| 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 11850 | |
| 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 7076 | |
| 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 31175 | |
| 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 318292 | |
| 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 350 | |
| 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 3800 | |
| 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 704423 | |
| 2018-07-31 | Class II | Nonconforming Material/Component | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | 1038 | 2022-09-20 |
| 2018-07-31 | Class II | Nonconforming Material/Component | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | 1798 | 2022-09-20 |
| 2018-07-31 | Class II | Nonconforming Material/Component | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | 1819 | 2022-09-20 |
| 2018-07-31 | Class II | Nonconforming Material/Component | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | 696 | 2022-09-20 |
| 2018-07-31 | Class II | Nonconforming Material/Component | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | 2806 | 2022-09-20 |
| 2012-02-16 | Not classified | Packaging process control | CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification. | 2 million | 2013-09-13 |
| 2012-02-16 | Not classified | Packaging process control | CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification. | 2 million | 2013-09-13 |
| 2012-02-16 | Not classified | Packaging process control | CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification. | 2 million | 2013-09-13 |
| 2011-12-01 | Not classified | Device Design | Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet | 84 boxes (2100 untis) | 2012-06-04 |
| 2011-12-01 | Not classified | Device Design | Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet | 481 boxes (12025 untis) | 2012-06-04 |
| 2011-12-01 | Not classified | Device Design | Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet | 19 units (475 boxes) | 2012-06-04 |
| 2011-12-01 | Not classified | Device Design | Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet | 187 boxes (4675 units) | 2012-06-04 |
| 2011-12-01 | Not classified | Device Design | Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet | 70 boxes (1750 unts) | 2012-06-04 |
| 2011-03-25 | Not classified | Equipment maintenance | fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient | ~1,250 units in US (50 boxes with 25 units ea) | 2012-03-19 |
| 2011-03-25 | Not classified | Equipment maintenance | fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient | 9,850 units in US (394 boxes with 25 units ea) | 2012-03-19 |
| 2011-03-25 | Not classified | Equipment maintenance | fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient | 300 units in US (12 boxes with 25 units ea) | 2012-03-19 |
| 2011-03-25 | Not classified | Equipment maintenance | fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient | 350 units in US (14 boxes with 25 units ea) | 2012-03-19 |
| 2010-05-26 | Not classified | Process design | The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment. | 2 units | 2012-06-21 |
| 2010-05-26 | Not classified | Process design | The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment. | 4275 units (171 boxes/25 units) | 2012-06-21 |
| 2009-06-30 | Not classified | Device Design | 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 electromagnetic radiation above the limits set | 326 units | 2010-10-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.