510(k) K980324 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
MICROSTREAM FILLERLINE OR/EMS
| Applicant | Oridion Medical , Ltd., Jerusalem, IL |
| Decision | Substantially Equivalent, Apr 16, 1998 |
| Received | Jan 28, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980324
| 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 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Jul 13, 2010 | Oridion Medical 1987 Ltd. Microstream FILTERLINE SET ADULT/PEDIATRIC 100 UN
Part Number: 010579-01 Terminated |
CCK | None listed |
| Jul 13, 2010 | Oridion Medical 1987 Ltd. Microstream FILTERLINE SET ADU/PED 25UN
Part Number: XS04620-01 Oridion
XS04661 Physio Control Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.