Sureline
Sureline 02 Pediatric 25UN
29manufacturers in China registered for this device type
1catalogue number
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 |
| Record published | 2016-09-25 |
| Record revised | 2024-01-22 (version 9) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2021-04-09 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 015101 | 25 | Withdrawn |
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
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.