510(k) · Cleared
ClearedDisposable Gas Sampling Lines
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Catheter Research, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Dec 27, 1994 after a 15-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Dec 27, 1994
- Review
- 15 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK946044 Disposable Gas Sampling LinesCatheter Research, Inc. · 1994
- Descendant · cites it directly · 2 of its ownK122075 Disposable Gas Sampling Line with and Without in-Line FilterIntersurgical, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK171678 Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg…Vyaire Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK192563 Altera gas Sampling LinesMeditera Tibbi Malzeme San VE Tic AS · 2020
- Descendant · 2 generations on · 0 of its ownK143150 CO2 monitoring line with and without in-line filterBesmed Health Business Corp · 2015
- Descendant · 2 generations on · 0 of its ownK133516 CO2 Monitoring Line, CO2 Monitoring Line with FilterFlexicare · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K122075Disposable Gas Sampling Line with and Without in-Line FilterIntersurgical, Inc. · 2012 · cites it directly2descendants
- K171678Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas…Vyaire Medical, Inc. · 2018 · cites it directly1descendant
- K192563Altera gas Sampling LinesMeditera Tibbi Malzeme San VE Tic AS · 2020 · 2 generations on0descendants
- K143150CO2 monitoring line with and without in-line filterBesmed Health Business Corp · 2015 · 2 generations on0descendants
- K133516CO2 Monitoring Line, CO2 Monitoring Line with FilterFlexicare · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946044 | Disposable Gas Sampling Lines | Catheter Research, Inc. | 1994 | — |
| +1 | K122075 | Disposable Gas Sampling Line with and Without in-Line Filter | Intersurgical, Inc. | 2012 | — |
| +1 | K171678 | Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg… | Vyaire Medical, Inc. | 2018 | — |
| +2 | K192563 | Altera gas Sampling Lines | Meditera Tibbi Malzeme San VE Tic AS | 2020 | — |
| +2 | K143150 | CO2 monitoring line with and without in-line filter | Besmed Health Business Corp | 2015 | — |
| +2 | K133516 | CO2 Monitoring Line, CO2 Monitoring Line with Filter | Flexicare | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
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, K122075 (Intersurgical, Inc., 2012) 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/K946044 · printed Nov 6, 2026
Cite this page
510(k) Report. “K946044: Disposable Gas Sampling Lines.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946044
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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