510(k) K181467 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line
| Applicant | Oridion Medical 1987 , Ltd., Jerusalem, IL |
| Decision | Substantially Equivalent, Feb 8, 2019 |
| Received | Jun 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181467
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.