510(k) · Cleared
ClearedDisposable Gas Sampling Line with and Without in-Line Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intersurgical, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Dec 20, 2012 as substantially equivalent to K946044 (Catheter Research, Inc., 1994) after a 157-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Dec 20, 2012
- Review
- 157 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946044 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK946044 Disposable Gas Sampling LinesCatheter Research, Inc. · 1994
- This deviceK122075 Disposable Gas Sampling Line with and Without in-Line FilterIntersurgical, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK143150 CO2 monitoring line with and without in-line filterBesmed Health Business Corp · 2015
- Descendant · cites it directly · 0 of its ownK133516 CO2 Monitoring Line, CO2 Monitoring Line with FilterFlexicare · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946044 | Disposable Gas Sampling Lines | Catheter Research, Inc. | 1994 | — |
| 0 (this device) | K122075 | Disposable Gas Sampling Line with and Without in-Line Filter | Intersurgical, Inc. | 2012 | — |
| +1 | K143150 | CO2 monitoring line with and without in-line filter | Besmed Health Business Corp | 2015 | — |
| +1 | K133516 | CO2 Monitoring Line, CO2 Monitoring Line with Filter | Flexicare | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 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? (1)
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 |
|---|---|---|---|
| * | K946044 | Disposable Gas Sampling LinesSummary page 1…me: Analyzer, Gas, Carbon Dioxide, Gaseous.Phase - Accessory - Classification Product Code: CCK Predicate Device: Catheter Research Inc., Disposable Gas Sampling Lines, K946044. The CR1 monitoring lines are designed for connection between a gas monitoring device and a patient interface device in which gas… | 1994 |
What descends from it? (2)
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?
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. 2012, this device’s year, is highlighted.
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 002 monitoring lines are intended to connedt from a 002 sampling port to the expired gas monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122075 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122075: Disposable Gas Sampling Line with and Without in-Line Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122075
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026