510(k) · Cleared
ClearedDisposable CO2 Gas Sampling/Oxygen Delivery Cannul
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospitak, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Feb 11, 1992 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 11, 1992
- Review
- 83 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK915228 Disposable CO2 Gas Sampling/Oxygen Delivery CannulHospitak, Inc. · 1992
- Descendant · cites it directly · 0 of its ownK140113 O2 Nasal Cannula with CO2 MonitoringFlexicare Medical, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK131410 CO2/O2 Nasal Cannula (with 4 (10CM) O2 and CO2 Tube), CO2/O2 Nasal…Southmedic, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK012395 Mac-Line 02/CO2 Nasal Cannula Sample LineOridion Medical 1987, Ltd. · 2001 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K140113O2 Nasal Cannula with CO2 MonitoringFlexicare Medical, Ltd. · 2014 · cites it directly0descendants
- K131410CO2/O2 Nasal Cannula (with 4 (10CM) O2 and CO2 Tube), CO2/O2 Nasal Cannula (with 8…Southmedic, Inc. · 2014 · cites it directly0descendants
- K012395Mac-Line 02/CO2 Nasal Cannula Sample LineOridion Medical 1987, Ltd. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915228 | Disposable CO2 Gas Sampling/Oxygen Delivery Cannul | Hospitak, Inc. | 1992 | — |
| +1 | K140113 | O2 Nasal Cannula with CO2 Monitoring | Flexicare Medical, Ltd. | 2014 | — |
| +1 | K131410 | CO2/O2 Nasal Cannula (with 4 (10CM) O2 and CO2 Tube), CO2/O2 Nasal Cannula… | Southmedic, Inc. | 2014 | — |
| +1 | K012395 | Mac-Line 02/CO2 Nasal Cannula Sample Line | Oridion Medical 1987, Ltd. | 2001 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2014 | 2 | 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? (3)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K140113 (Flexicare Medical, Ltd., 2014) has gone furthest, with 0 descendants 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/K915228 · printed Nov 5, 2026
Cite this page
510(k) Report. “K915228: Disposable CO2 Gas Sampling/Oxygen Delivery Cannul.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K915228
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026