510(k) · Cleared
Recalled · 2012Mac-Line CO2 Nasal Cannula Sample Line
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 Aug 15, 2001 as substantially equivalent to K863703 (Salter Labs, 1986) and 1 other predicate after a 19-day review. Its family tree reaches back 3 generations to 1995. It has been recalled 3 times.
- Decided
- Aug 15, 2001
- Review
- 19 days
- Class
- Class II
- Product code
- CCK
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 3 generations to K950387 (1995). 4 ancestors in all, the oldest K863703 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK950387 GeminiSpegas Industries, Ltd. · 1995
- 2 generations backK964239 Combination Oximeter/Carbon Dioxide Gas AnalyzerSpegas Industries, Ltd. · 1997
- 1 generation backK980325 Microstream Nasal Cannula FilterlineOridion Medical, Ltd. · 1998 · Recalled
- This deviceK012391 Mac-Line CO2 Nasal Cannula Sample LineOridion Medical 1987, Ltd. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950387 | Gemini | Spegas Industries, Ltd. | 1995 | — |
| −2 | K964239 | Combination Oximeter/Carbon Dioxide Gas Analyzer | Spegas Industries, Ltd. | 1997 | — |
| −1 | K980325 | Microstream Nasal Cannula Filterline | Oridion Medical, Ltd. | 1998 | 3 |
| 0 (this device) | K012391 | Mac-Line CO2 Nasal Cannula Sample Line | Oridion Medical 1987, Ltd. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K863703 | Salter Labs Model 4000 Nasal CO2 Sample LineSummary page 2…MAC-Line CO, Nasal Cannula sample line is Substantial Equivalent to the Salter Laboratories Nasal Cannula (Adult model 4000, Pediatric model 4100 and Infant mode! 4200) K863703 and the Oridion Microstream Nasal Cannula Filterline (K980325 ) madified by removing the hydrophaobic in line filter Oridion Med… | 1986 |
| * | K980325 | Microstream Nasal Cannula FilterlineSummary page 1…on the other end for connecting to the Capnograph. The design and construction of the Microstream Nasal Cannula is identical to the Microstream Nasal Cannula Filterline (K980325) except for the modification of removing the in line hydrophobic filter The two connectors are joined by a plastic tube. Oridio… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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-1333-2012 | Packaging process control | CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification. |
| Dec 1, 2011 | Not classified | Z-1346-2012 | Device Design | Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet |
| Dec 1, 2011 | Not classified | Z-1347-2012 | Device Design | Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K863703.
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 | — |
What is it indicated for?
The MAC-Line CO, Nasal Cannula sample line is used whenever the physician needs to measure the CO,in a patient's breathing in a non intubated patient.
The intended use of the MAC-Line CO, Nasal Cannula sample line is to conduct a sample of the patient's breathing from the patient to the gas measurement device for measuring the percentage of CO; in the patient’s exhalation. The intended use of the modified device, as described in its labeling, has not changed as a result of the modification.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012391 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012391: Mac-Line CO2 Nasal Cannula Sample Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012391
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026