510(k) · Cleared
Recalled · 2012Modification to: Mac-Line O2/CO2 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 Nov 29, 2001 as substantially equivalent to K011536 (Oridion Medical 1987, Ltd., 2001) and 1 other predicate after a 9-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Nov 29, 2001
- Review
- 9 days
- Class
- Class II
- Product code
- CCK
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K864902 (1987). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK864902 Mod. 4003 Adu., Oxy. Delive.-Oral/Nasal CO2 Cannu.Salter Labs · 1987
- This deviceK013845 Modification to: Mac-Line O2/CO2 Oral Nasal Cannula Sample LineOridion Medical 1987, Ltd. · 2001
- 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 1 of 1 · See all- K181624Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream…Oridion Medical 1987, Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864902 | Mod. 4003 Adu., Oxy. Delive.-Oral/Nasal CO2 Cannu. | Salter Labs | 1987 | — |
| 0 (this device) | K013845 | Modification to: Mac-Line O2/CO2 Oral Nasal Cannula Sample Line | Oridion Medical 1987, Ltd. | 2001 | — |
| +1 | K181624 | Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing… | Oridion Medical 1987, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K011536 | Microstream O2/CO2 Oral Nasal Filterline | 2001 |
| * | K864902 | Mod. 4003 Adu., Oxy. Delive.-Oral/Nasal CO2 Cannu.Summary page 2…tial Equivalent to: a. Microstream O,/CO. Oral Nasal Cannula FilterLine KO11536. b. Salter Labs PN 4003 Adult dual oral nasal CO, sample cannula with oxygen delivery. (K864902). c. Salter Labs PN 4103 Pediatric dual oral nasal CO, sample cannula with oxygen delivery. (K864902). Oridion Medical 1967 Ltd… | 1987 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181624 | Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream… | 2019 | 0 |
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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 0,/CO, Oral Nasal Cannula sample line is used whenever the physician needs to collect a sample of the patient's breathing to measure CO, with a capnograph while simultaneously administering supplemental oxygen near the nose and mouth for inhalation. It can be used for adult, intermediate or pediatric non-intubated patients.
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/K013845 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013845: Modification to: Mac-Line O2/CO2 Oral 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/K013845
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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