# K010024: O2/CO2 Nasal Filterline

- Pathway: 510(k) (Traditional)
- Applicant: Oridion Medical 1987, Ltd.
- Decided: Mar 14, 2001 after 70 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K213767: Endure ETCO2/02 Nasal Cannula (2023), 0 descendants of its own
- 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 (2019), 0 descendants of its own
- K162343: Westmed Gas Sampling Cannula with O2 delivery (2016), 0 descendants of its own
- K143127: CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style (2015), 0 descendants of its own

## Recalls of this device
- 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.
- May 26, 2010 · Not classified · Z-1999-2010: 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-2002-2010: 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

Source page: https://510kreport.com/device/K010024
Methodology: https://510kreport.com/methodology