510(k) · Cleared
ClearedSalter Labs #4001 Oral Nasal CO2 Sampling Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Salter Labs · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Feb 10, 1987 after a 106-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Feb 10, 1987
- Review
- 106 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK864199 Salter Labs #4001 Oral Nasal CO2 Sampling CannulaSalter Labs · 1987
- Descendant · cites it directly · 2 of its ownK151421 Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2…Salter Labs · 2016
- Descendant · 2 generations on · 1 of its ownK181981 CO2 Sampling LineTylenol Medical Instruments Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK251216 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling…Barbaras Development, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK012394 Oridion Mac-Line Oral Nasal Cannula Sample LineOridion Medical 1987, Ltd. · 2001
Most influential descendants
Showing 4 of 4 · See all- K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula…Salter Labs · 2016 · cites it directly2descendants
- K181981CO2 Sampling LineTylenol Medical Instruments Co., Ltd. · 2019 · 2 generations on1descendant
- K2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2…Barbaras Development, Inc. · 2025 · 3 generations on0descendants
- K012394Oridion Mac-Line Oral 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) | K864199 | Salter Labs #4001 Oral Nasal CO2 Sampling Cannula | Salter Labs | 1987 | — |
| +1 | K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2… | Salter Labs | 2016 | — |
| +2 | K181981 | CO2 Sampling Line | Tylenol Medical Instruments Co., Ltd. | 2019 | — |
| +3 | K251216 | 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182… | Barbaras Development, Inc. | 2025 | — |
| +1 | K012394 | Oridion Mac-Line Oral Nasal Cannula Sample Line | Oridion Medical 1987, Ltd. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 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? (4)
2 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, K151421 (Salter Labs, 2016) has gone furthest, with 2 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/K864199 · printed Nov 4, 2026
Cite this page
510(k) Report. “K864199: Salter Labs #4001 Oral Nasal CO2 Sampling Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K864199
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026