# K980324: Microstream Fillerline or/Ems

- Pathway: 510(k) (Traditional)
- Applicant: Oridion Medical, Ltd.
- Decided: Apr 16, 1998 after 78 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K950387 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964239: Combination Oximeter/Carbon Dioxide Gas Analyzer, Spegas Industries, Ltd. (1997) Summary page 1.

## Most influential descendants
- K181467: Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line (2019), 0 descendants of its own

## Recalls of this device
- Apr 7, 2025 · Class II · Z-1722-2025: Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
- Feb 16, 2012 · Not classified · Z-1333-2012: CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.
- Feb 16, 2012 · Not classified · Z-1334-2012: CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.
- Feb 16, 2012 · Not classified · Z-1332-2012: CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.
- Dec 1, 2011 · Not classified · Z-1349-2012: Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet
- May 26, 2010 · Not classified · Z-2010-2010: 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 t
- May 26, 2010 · Not classified · Z-2012-2010: 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 t

## Indications for use
THE MICROSTREAM FILTERLINE OR/EMS DEVICE IS USED WHENEVER THE PHYSICIAN NEEDS TO MEASURE THE CO; IN AN INTUBATED PATIENT'S BREATHING.

Source page: https://510kreport.com/device/K980324
Methodology: https://510kreport.com/methodology