510(k) · Cleared
ClearedGas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vyaire Medical, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Apr 30, 2018 as substantially equivalent to K946044 (Catheter Research, Inc., 1994) after a 328-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Apr 30, 2018
- Review
- 328 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946044 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK946044 Disposable Gas Sampling LinesCatheter Research, Inc. · 1994
- This deviceK171678 Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg…Vyaire Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK192563 Altera gas Sampling LinesMeditera Tibbi Malzeme San VE Tic AS · 2020
Most influential descendants
Showing 1 of 1 · See all- K192563Altera gas Sampling LinesMeditera Tibbi Malzeme San VE Tic AS · 2020 · cites it directly0descendants
View 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) | K171678 | Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg… | Vyaire Medical, Inc. | 2018 | — |
| +1 | K192563 | Altera gas Sampling Lines | Meditera Tibbi Malzeme San VE Tic AS | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 4…21 CFR 868.1400 Regulatory Class: II Product Code: CCK 3. Predicate Device Disposable Gas Sampling Line cleared under K946044 on December 27, 1994. This predicate device has not been subject to a design-related recall. 4. Device Description Vital S… | 1994 |
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 |
|---|---|---|---|
| K192563 | Altera gas Sampling Lines | 2020 | 0 |
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. 2018, 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 Vital Signs Gas Sampling Lines are intended to connect from a port in the breathing circuit to the expired gas monitor. These gas sampling lines are used with GE Healthcare Compact Airway modules and CARESCAPE Respiratory modules for monitoring CO2, O2, N2O and anesthetic agents and with E-miniC for monitoring CO2.
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/K171678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171678: Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171678
Report an extraction error
Are you the manufacturer?
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