Panels › Anesthesiology › Product code CCK · Class 2
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Regulation 868.1400
3510(k)s in 12 months (307 all time)
0recalls in 12 months (98 all time)
89recalls that name a 510(k)
Top companies in CCK
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2025 | Philips North America Llc Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2 Open, Classified |
CCK | K113441 K181467 +3 |
| Mar 20, 2025 | Smiths Medical ASD, Inc. CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214 Open, Classified |
CCK | K941982 |
| Mar 20, 2025 | Smiths Medical ASD, Inc. CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100 Open, Classified |
CCK | K871133 |
| Mar 17, 2025 | Oridion Medical 1987 Ltd. Microstream Instructions for Use and Part Number used with - Product Description, REF:
Microstream Advance Intubated Infant, PT00156250 -
Microstream Advance Neonatal-Infant Intubated CO2 Filter L Open, Classified |
CCK | K181467 |
| Mar 17, 2025 | Oridion Medical 1987 Ltd. Microstream Instructions for Use and Part Number used with - Product Description, REF:
Microstream Advance Intubated Adult-Pediatric, PT00156254 -
Microstream Advance Adult-Pediatric Intubated CO2 Open, Classified |
CCK | K181467 |
| Mar 17, 2025 | Oridion Medical 1987 Ltd. Microstream Instructions for Use and Part Number used with - Product Description, REF:
Microstream Luer Intubated Adult Pediatric, PT00156355 -
Microstream Luer Adult-Pediatric Intubated CO2 Sampl Open, Classified |
CCK | K181467 |
| Mar 17, 2025 | Oridion Medical 1987 Ltd. Microstream Instructions for Use and Part Number used with - Product Description, REF:
Microstream Adv. Infant Intubated, PT00134354 -
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line Open, Classified |
CCK | K181467 |
| Mar 17, 2025 | Oridion Medical 1987 Ltd. Microstream Instructions for Use and Part Number used with - Product Description, REF:
Microstream Adv. Adult-Pediatric Intubated, PT00134333 -
Microstream Advance Adult-Pediatric Intubated CO2 Fi Open, Classified |
CCK | K181467 |
| Mar 17, 2025 | Oridion Medical 1987 Ltd. Microstream Instructions for Use and Part Number used with - Product Description, REF:
OmniVentLine Set, 012808 -
OmniVentLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 012495; Open, Classified |
CCK | K181467 |
| Mar 17, 2025 | Oridion Medical 1987 Ltd. Microstream Instructions for Use and Part Number used with - Product Description, REF:
Airway Adapter and CO2 Sampling Line, 01158 -
Microstream Luer Adult-Pediatric Airway Adapter, 010989;
Omnis Open, Classified |
CCK | K181467 |
| Mar 17, 2025 | Oridion Medical 1987 Ltd. Microstream Instructions for Use and Part Number used with - Product Description, REF:
Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 -
CapnoLine Neonatal-Infant Intubated Filter Lin Open, Classified |
CCK | K181467 |
| Mar 17, 2025 | Oridion Medical 1987 Ltd. Microstream Instructions for Use and Part Number used with - Product Description, REF:
FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 -
MICROSTREAM FilterLine H Set Long Adult-Pediatric Open, Classified |
CCK | K181467 |
| Mar 17, 2025 | Oridion Medical 1987 Ltd. Microstream Instructions for Use and Part Number used with - Product Description, REF:
FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 S Open, Classified |
CCK | K181467 |
| Nov 6, 2024 | Nihon Kohden America Inc Adult Cap-ONE Biteblock REF YG-227T
The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 20mm bite block, during endoscopy type procedures. Open, Classified |
CCK | K171765 |
| May 25, 2021 | Southmedic, Inc. OxyMask O2 Adult REF OM-1125-14 Open, Classified |
CCK | None listed |
| Nov 16, 2020 | Covidien Llc Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or Open, Classified |
CCK | K150272 |
| Jan 10, 2020 | GE Healthcare, LLC Airway Gas Option N-CAiO Terminated |
CCK | K133576 |
| Jan 10, 2020 | GE Healthcare, LLC CARESCAPE Respiratory Module E-sCAiOVE Terminated |
CCK | None listed |
| Jan 10, 2020 | GE Healthcare, LLC CARESCAPE Respiratory Module E-sCAiOE Terminated |
CCK | None listed |
| Jan 10, 2020 | GE Healthcare, LLC CARESCAPE Respiratory Module E-sCAiOV Terminated |
CCK | K123195 K150245 +2 |
| Jan 10, 2020 | GE Healthcare, LLC CARESCAPE Respiratory Module E-sCAiO Terminated |
CCK | K123195 K150245 +2 |
| Jan 10, 2020 | GE Healthcare, LLC CARESCAPE Respiratory Module E-sCOVX Terminated |
CCK | K150245 K171028 +1 |
| Jan 10, 2020 | GE Healthcare, LLC CARESCAPE Respiratory Module E-sCO Terminated |
CCK | K123195 K150245 +2 |
| Jul 1, 2019 | CareFusion 303, Inc. Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933 Terminated |
CCK | K031741 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03 Terminated |
CCK | K112368 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01 Terminated |
CCK | K112368 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02 Terminated |
CCK | K112368 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657 Terminated |
CCK | K082268 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (US) N, Part Number CS08651-01 Terminated |
CCK | K112368 |
| Jan 25, 2018 | Southmedic, Inc. Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case.
Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breath Terminated |
CCK | K014211 |
| Nov 29, 2017 | Smiths Medical ASD Inc. BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain functions being installe Terminated |
CCK | K030407 |
| Jun 1, 2016 | Ventlab LLC STAT-Check Resuscitation Bag
Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer
Intended for use in various clinical situations to provide respiratory support in the presence of rever Terminated |
CCK | K093525 K982215 |
| May 12, 2016 | Medtronic Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520.
Battery Pack used with the Capnostream"20 and Capnostream"20p Patient Monito Terminated |
CCK | K123690 |
| Dec 21, 2015 | CareFusion 303, Inc. Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). Terminated |
CCK | K031741 |
| May 29, 2015 | Smiths Medical ASD, Inc. Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A. Terminated |
CCK | K030407 |
| Jul 18, 2014 | GE Healthcare, LLC DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES.
DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only).
E-miniC and accessories is indicate Terminated |
CCK | K043276 K052582 |
| Nov 19, 2013 | SALTER LABS Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors.
Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road,
Arvin, CA 93203.
CO2 sample line. Terminated |
CCK | K894350 |
| Mar 29, 2013 | Smiths Medical ASD, Inc. Smiths Medical, BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dioxide measurement equipment. Product Usage: The B Terminated |
CCK | K970209 |
| Jun 27, 2012 | SALTER LABS Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector.
7 ft, oxygen tube, 7 ft. CO2 tube
RX only.For Single Patient Use only.
Distributed by Tri-Anium
Assembled in Mexico.
Usage: De Terminated |
CCK | K892406 |
| Mar 30, 2012 | Oridion Medical 1987 Ltd. Oridion Surestream CO2 Sampling Lines-
Sure VentLine H Set Adult/Pediatric
Part Number: 010987-03
Product Usage:
The intended use of SureStream sampling lines is to convey a sample of a patients exp Terminated |
CCK | K980327 |
| Mar 30, 2012 | Oridion Medical 1987 Ltd. Oridion Surestream CO2 Sampling Lines-
Sure VentLine Set Adult/Pediatric
Part Number: 010986-03
Product Usage:
The intended use of SureStream sampling lines is to convey a sample of a patients expire Terminated |
CCK | K980324 |
| Mar 30, 2012 | Oridion Medical 1987 Ltd. Oridion Surestream CO2 Sampling Lines-
SureLine O2
Part Number: 010979-03
Product Usage:
The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnogr Terminated |
CCK | K012395 |
| Mar 30, 2012 | Oridion Medical 1987 Ltd. Oridion Surestream CO2 Sampling Lines-
Smart SureLine Plus O2 adult
Part Number: 010981-03
Product Usage:
The intended use of SureStream sampling lines is to convey a sample of a patients expired bre Terminated |
CCK | K012391 |
| Mar 30, 2012 | Oridion Medical 1987 Ltd. Oridion Surestream CO2 Sampling Lines-
SureLine Adult
Part Number: 010976-03
Product Usage:
The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capn Terminated |
CCK | K012391 |
| Mar 29, 2012 | Oridion Medical 1987 Ltd. Oridion CO2 sampling lines and water traps under the label:
Omnistream CO2 Sampling Lines:
OmniLine O2 Adult Part No.007609;
OmniLine O2 Pediatric Part No 007610;
Smart OmniLine Plu Terminated |
CCK | K012395 K013845 +3 |
| Mar 29, 2012 | Oridion Medical 1987 Ltd. Oridion CO2 sampling lines and water traps under the label:
Surestream CO2 Sampling Lines:
SureLine Adult Part No.010976;
sureLine Pediatric Part No. 010977;
SureLine O2 Adult Part No.010979 Terminated |
CCK | K012391 K012395 +4 |
| Mar 29, 2012 | Oridion Medical 1987 Ltd. Oridion CO2 sampling lines and water traps under the label:
MicroStreamC02 Sampling Lines:
FilterLine Set Adult/Pediatric -Part No: XS04620-01;
FilterLine Set Adult/Pediatric (100 unit boxes)-Part Terminated |
CCK | K010024 K011050 +4 |
| Jan 11, 2012 | SALTER LABS ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707 7-7-24.
Salter Labs Nasal Cannula (Adult), Salter Style
with modified nasal prongs.
w/7' O2 line and 7' CO2 line wi Terminated |
CCK | K892406 |
| May 26, 2011 | Philips Healthcare Inc. Philips Microstream Model 989803159581 VITALINE H SET INFANT/NEONATAL 25 UN PHILIPS
These products are used with Philips Monitors for the measurement of endtidal CO2 in infants and neonates. They pro Terminated |
CCK | K980327 |
| May 26, 2011 | Philips Healthcare Inc. Philips Microstream Model M1923A FILTERLINE H SET INF/NEO 25UN PHILIPS
These products are used with Philips Monitors for the measurement of endtidal CO2 in infants and neonates. They provide a means Terminated |
CCK | K980327 |
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