510(k) · Cleared
ClearedOridion Mac-Line Oral 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 K011050 (Oridion Medical 1987, Ltd., 2001) and 1 other predicate after a 19-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Aug 15, 2001
- Review
- 19 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K864199 (1987). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK864199 Salter Labs #4001 Oral Nasal CO2 Sampling CannulaSalter Labs · 1987
- This deviceK012394 Oridion Mac-Line Oral 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 | K864199 | Salter Labs #4001 Oral Nasal CO2 Sampling Cannula | Salter Labs | 1987 | — |
| 0 (this device) | K012394 | Oridion Mac-Line Oral Nasal Cannula Sample Line | Oridion Medical 1987, Ltd. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K011050 | Microstream Oral Nasal Cannula FilterlineSummary page 2…'s exhalation. SUBSTANTIAL EQUIVALENCE: The Oridion MAC-Line Oral Nasal Cannula sample line is substantial equivalent to the Microstream Oral Nasal Cannula Filterline (K011050) and the Salter Labs Model 4001 Adult, Salter Labs Model 4101 Pediatric (FDA K864199), Oral Nasal Cannula, these devices legally… | 2001 |
| * | K864199 | Salter Labs #4001 Oral Nasal CO2 Sampling CannulaSummary page 2…ple line is substantial equivalent to the Microstream Oral Nasal Cannula Filterline (K011050) and the Salter Labs Model 4001 Adult, Salter Labs Model 4101 Pediatric (FDA K864199), Oral Nasal Cannula, these devices legally marketed in the USA Oridion Medical 1987 Ltd. « POB 45025 - Jerusalem 91450 Israel… | 1987 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K011050.
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 Oridion MAC-Line Oral Nasal Cannula sample line device 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 Oridion MAC-Line Oral 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 COz 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/K012394 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012394: Oridion Mac-Line Oral Nasal Cannula Sample Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012394
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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