510(k) · Cleared
Recalled · 2012Mac-Line 02/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 K915228 (Hospitak, Inc., 1992) after a 19-day review. Its family tree reaches back 1 generation to 1992. It has been recalled 3 times.
- Decided
- Aug 15, 2001
- Review
- 19 days
- Class
- Class II
- Product code
- CCK
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915228 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK915228 Disposable CO2 Gas Sampling/Oxygen Delivery CannulHospitak, Inc. · 1992
- This deviceK012395 Mac-Line 02/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 |
|---|---|---|---|---|---|
| −1 | K915228 | Disposable CO2 Gas Sampling/Oxygen Delivery Cannul | Hospitak, Inc. | 1992 | — |
| 0 (this device) | K012395 | Mac-Line 02/CO2 Nasal Cannula Sample Line | Oridion Medical 1987, Ltd. | 2001 | — |
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? (3)
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 |
|---|---|---|---|
| * | K915228 | Disposable CO2 Gas Sampling/Oxygen Delivery CannulSummary page 2…a O, supply nasal cannuia. e The MAC-Line O,/CO, Nasal Cannula sample line is essentially equivalent to the Hospitak disposable CO, Gas sampling/Oxygen delivery Cannula K915228. ¢ The Oridion Pediatric MAC-Line O2/CO2 Nasal Cannula sample line is essentially equivalent to the Salter Laboratories Model 47… | 1992 |
| * | — | Oridion O₂/CO₂ Microstream Nasal Cannula Filterline Named without a submission number | |
| * | — | Salter Laboratories Model 4701 CO₂ Gas sampling/Oxygen delivery Cannula Named without a submission number | |
| † | K980325 | Microstream Nasal Cannula Filterline | 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. |
| Feb 16, 2012 | Not classified | Z-1334-2012 | 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-1348-2012 | 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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K915228.
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 O,/CO, Nasal Cannula sample line device is used whenever the physician needs to measure the CO, in an adult or pediatric non intubated subject’s breathing via a nasal cannula while simultaneously administering supplemental oxygen near the nose and mouth for inhalation.
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/K012395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012395: Mac-Line 02/CO2 Nasal Cannula Sample Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012395
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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