Data / Medical devices / Israel / Oridion Medical 1987 Ltd.
Oridion Medical 1987 Ltd.: FDA-registered device maker in Jerusalem, Israel, 21 510(k) clearances
Oridion Medical 1987 Ltd. is registered with the FDA (registration 8044004) in Jerusalem, Israel. It lists 12 device types. The FDA files 21 510(k) clearances under its listings, the newest dated February 26, 2024. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8044004
- FEI number
- 3001227743
- Address
- 7 Hamarpe ST. P.O. Box 45025, Jerusalem, Israel, 9777407
- Owner or operator
- Covidien llc (1282497)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 23, 2002
- Registered through
- 2026
- Brand names listed
- Advance Adult-Pediatric Intubated, 4M, short-term, Airway adapter, BIS Sensor Simulator, BIS Advance Monitoring System, CARESCAPE CO2 Microstream parameter, Capnostream20p, Capnostream35 Portable Respiratory Monitor, Carinal VitaLine Set and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 26, 2024 | K230693 | BIS Advance Monitoring System | OLW | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| July 29, 2022 | K213911 | Microstream CO2 NanoPod | CCK | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| April 12, 2022 | K213518 | CARESCAPE CO2 Microstream parameter | CCK | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| April 27, 2020 | K200594 | Capnostream 35 Portable Respiratory Monitor | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| March 22, 2019 | K181624 | Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| February 8, 2019 | K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| April 16, 2015 | K143506 | BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES) | GXY | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 5, 2014 | K123690 | CAPNOSTREAM20P WITH HIFI C02 MONITORING | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| November 29, 2012 | K121927 | MICROSTREAM FILTERLINE ICU | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| March 4, 2010 | K093388 | SMART CAPNOLINE GUARDIAN | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| November 20, 2007 | K072286 | BIS EEG VISTA MONITOR SYSTEM AND BISX | OLW | Substantially Equivalent | Aspect Medical Systems, Inc. | accessdata.fda.gov |
| November 29, 2001 | K013845 | MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| November 14, 2001 | K011536 | MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| August 15, 2001 | K012395 | MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| August 15, 2001 | K012394 | ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| August 15, 2001 | K012391 | MAC-LINE CO2 NASAL CANNULA SAMPLE LINE | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| May 4, 2001 | K011050 | MICROSTREAM ORAL NASAL CANNULA FILTERLINE | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| March 14, 2001 | K010024 | O2/CO2 NASAL FILTERLINE | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| April 16, 1998 | K980327 | MICROSTREAM FILTERLINE ICU | CCK | Substantially Equivalent | Oridion Medical , Ltd. | accessdata.fda.gov |
| April 16, 1998 | K980325 | MICROSTREAM NASAL CANNULA FILTERLINE | CCK | Substantially Equivalent | Oridion Medical , Ltd. | accessdata.fda.gov |
| April 16, 1998 | K980324 | MICROSTREAM FILLERLINE OR/EMS | CCK | Substantially Equivalent | Oridion Medical , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 17, 2025 | 96309 | Class II | Ongoing | 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 Sampling Line and Airway | 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. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, as | accessdata.fda.gov |
| July 31, 2018 | 80895 | Class II | Terminated | CAPNOSTREAM 20 (US) N, Part Number CS08651 | 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. | accessdata.fda.gov |
| February 16, 2012 | 61329 | Not yet classified | Terminated | 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 No. 010579; FilterLine | CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification. | accessdata.fda.gov |
| December 1, 2011 | 61143 | Not yet classified | Terminated | 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 capnograph in order to mea | Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet | accessdata.fda.gov |
| March 25, 2011 | 58373 | Not yet classified | Terminated | MicroStream Filterline Infant/Neonatal products: Part # 006285 - FILTERLINE H SET INF/NEO 25 UN PHYSIO (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are | fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient | accessdata.fda.gov |
| May 26, 2010 | 55790 | Not yet classified | Terminated | Microstream O2/CO2 NASAL FILTERLINE ADULT 25UN Part Number: 006912 | 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. | accessdata.fda.gov |
| June 30, 2009 | 52959 | Not yet classified | Terminated | Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. Part numbers CS 08651, CS 08653, CS08657, and CS08659. | 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 by applicable standards for medical devices | accessdata.fda.gov |
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Updated March 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.