ClearanceBrief
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)
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Top companies in CCK

DateFirm and productCodeLinked 510(k)
May 5, 2025Philips 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
CCKK113441
K181467 +3
Mar 20, 2025Smiths Medical ASD, Inc.
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
Open, Classified
CCKK941982
Mar 20, 2025Smiths Medical ASD, Inc.
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Open, Classified
CCKK871133
Mar 17, 2025Oridion 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
CCKK181467
Mar 17, 2025Oridion 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
CCKK181467
Mar 17, 2025Oridion 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
CCKK181467
Mar 17, 2025Oridion 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
CCKK181467
Mar 17, 2025Oridion 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
CCKK181467
Mar 17, 2025Oridion 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
CCKK181467
Mar 17, 2025Oridion 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
CCKK181467
Mar 17, 2025Oridion 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
CCKK181467
Mar 17, 2025Oridion 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
CCKK181467
Mar 17, 2025Oridion 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
CCKK181467
Nov 6, 2024Nihon 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
CCKK171765
May 25, 2021Southmedic, Inc.
OxyMask O2 Adult REF OM-1125-14
Open, Classified
CCKNone listed
Nov 16, 2020Covidien 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
CCKK150272
Jan 10, 2020GE Healthcare, LLC
Airway Gas Option N-CAiO
Terminated
CCKK133576
Jan 10, 2020GE Healthcare, LLC
CARESCAPE Respiratory Module E-sCAiOVE
Terminated
CCKNone listed
Jan 10, 2020GE Healthcare, LLC
CARESCAPE Respiratory Module E-sCAiOE
Terminated
CCKNone listed
Jan 10, 2020GE Healthcare, LLC
CARESCAPE Respiratory Module E-sCAiOV
Terminated
CCKK123195
K150245 +2
Jan 10, 2020GE Healthcare, LLC
CARESCAPE Respiratory Module E-sCAiO
Terminated
CCKK123195
K150245 +2
Jan 10, 2020GE Healthcare, LLC
CARESCAPE Respiratory Module E-sCOVX
Terminated
CCKK150245
K171028 +1
Jan 10, 2020GE Healthcare, LLC
CARESCAPE Respiratory Module E-sCO
Terminated
CCKK123195
K150245 +2
Jul 1, 2019CareFusion 303, Inc.
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
Terminated
CCKK031741
Jul 31, 2018Oridion Medical 1987 Ltd.
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03
Terminated
CCKK112368
Jul 31, 2018Oridion Medical 1987 Ltd.
CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Terminated
CCKK112368
Jul 31, 2018Oridion Medical 1987 Ltd.
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Terminated
CCKK112368
Jul 31, 2018Oridion Medical 1987 Ltd.
CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Terminated
CCKK082268
Jul 31, 2018Oridion Medical 1987 Ltd.
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Terminated
CCKK112368
Jan 25, 2018Southmedic, 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
CCKK014211
Nov 29, 2017Smiths 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
CCKK030407
Jun 1, 2016Ventlab 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
CCKK093525
K982215
May 12, 2016Medtronic
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
CCKK123690
Dec 21, 2015CareFusion 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
CCKK031741
May 29, 2015Smiths Medical ASD, Inc.
Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
Terminated
CCKK030407
Jul 18, 2014GE 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
CCKK043276
K052582
Nov 19, 2013SALTER 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
CCKK894350
Mar 29, 2013Smiths 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
CCKK970209
Jun 27, 2012SALTER 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
CCKK892406
Mar 30, 2012Oridion 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
CCKK980327
Mar 30, 2012Oridion 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
CCKK980324
Mar 30, 2012Oridion 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
CCKK012395
Mar 30, 2012Oridion 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
CCKK012391
Mar 30, 2012Oridion 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
CCKK012391
Mar 29, 2012Oridion 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
CCKK012395
K013845 +3
Mar 29, 2012Oridion 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
CCKK012391
K012395 +4
Mar 29, 2012Oridion 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
CCKK010024
K011050 +4
Jan 11, 2012SALTER 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
CCKK892406
May 26, 2011Philips 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
CCKK980327
May 26, 2011Philips 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
CCKK980327

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