510(k) · Cleared
Recalled · 2012Microstream O2/CO2 Oral Nasal Filterline
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oridion Medical 1987, Ltd. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Nov 14, 2001 after a 180-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 7 times.
- Decided
- Nov 14, 2001
- Review
- 180 days
- Class
- Class II
- Product code
- CCK
- Recalls
- 7
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK011536 Microstream O2/CO2 Oral Nasal FilterlineOridion Medical 1987, Ltd. · 2001
- Descendant · cites it directly · 1 of its ownK013845 Modification to: Mac-Line O2/CO2 Oral Nasal Cannula Sample LineOridion Medical 1987, Ltd. · 2001 · Recalled
- Descendant · cites it directly · 0 of its ownK181624 Microstream Advance Neonatal-Infant Nasal Filter Line with O2…Oridion Medical 1987, Ltd. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011536 | Microstream O2/CO2 Oral Nasal Filterline | Oridion Medical 1987, Ltd. | 2001 | — |
| +1 | K013845 | Modification to: Mac-Line O2/CO2 Oral Nasal Cannula Sample Line | Oridion Medical 1987, Ltd. | 2001 | 2 |
| +1 | K181624 | Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing… | Oridion Medical 1987, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CCK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CCK device
- #1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 16, 2012 | Not classified | Z-1332-2012 | Packaging process control | 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-2007-2010 | Process design | 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. |
| May 26, 2010 | Not classified | Z-2004-2010 | Process design | 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. |
| May 26, 2010 | Not classified | Z-2008-2010 | Process design | 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. |
| May 26, 2010 | Not classified | Z-2009-2010 | Process design | 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. |
| May 26, 2010 | Not classified | Z-2013-2010 | Process design | 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. |
| May 26, 2010 | Not classified | Z-2005-2010 | Process design | 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. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013845 (Oridion Medical 1987, Ltd., 2001) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CCK devicesCCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCK
169in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CCK
1in 2022
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · CCK
1,259in 2025
MAUDE reports naming product code CCK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 56 | 0 | 7 |
| 2008 | 3 | 248 | 1 | 20 |
| 2009 | 3 | 101 | 19 | 21 |
| 2010 | 3 | 125 | 4 | 12 |
| 2011 | 2 | — | 14 | 18 |
| 2012 | 7 | 150 | 3 | 13 |
| 2013 | 4 | 132 | 2 (1) | 28 |
| 2014 | 9 | 166 | 0 | 51 |
| 2015 | 5 | 105 | 1 | 114 |
| 2016 | 2 | — | 0 | 88 |
| 2017 | 5 | 134 | 0 | 58 |
| 2018 | 6 | 296 | 5 | 63 |
| 2019 | 7 | 261 | 7 (7) | 141 |
| 2020 | 4 | 188 | 1 | 2,302 |
| 2021 | 4 | 227 | 0 | 2,272 |
| 2022 | 3 | 226 | 1 | 2,475 |
| 2023 | 4 | 555 | 0 | 1,637 |
| 2024 | 3 | 592 | 0 | 1,216 |
| 2025 | 3 | 169 | 0 | 1,259 |
| 2026 | 3 | 224 | 0 | — |
https://510kreport.com/device/K011536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011536: Microstream O2/CO2 Oral Nasal Filterline.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011536
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026