510(k) · Cleared
ClearedAirway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bluepoint Medical GmbH & Co. KG · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Dec 18, 2019 as substantially equivalent to K051092 (GE Healthcare, 2005) after a 261-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Dec 18, 2019
- Review
- 261 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001814 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK001814 Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01)…Datex-Ohmeda · 2000
- 1 generation backK051092 Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx)…GE Healthcare · 2005 · Recalled
- This deviceK190824 Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft…Bluepoint Medical GmbH & Co. KG · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001814 | Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and… | Datex-Ohmeda | 2000 | — |
| −1 | K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx… | GE Healthcare | 2005 | 2 |
| 0 (this device) | K190824 | Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas… | Bluepoint Medical GmbH & Co. KG | 2019 | — |
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 |
|---|---|---|---|
| * | K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov…Summary page 4…Class II (3) Predicate Device: Substantial Equivalence to: K Number Model Manufacturer K051092 Gas Sampling Line, disposable, GE Healthcare PVC/PE, included accessories in:… | 2005 |
| † | K946044 | Disposable Gas Sampling Lines | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 14.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 7 other devices also cite its predicate K051092.
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. 2019, 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 Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases. The Airway Gas Sampling Products are single patient use devices with a cumulative duration of use of up to 72 hours. The Airway Gas Sampling Products include Airway Gas Sampling Sets with integrated gas sampling lines, and an Airway Adapter without sample line, both for use with compatible GE Healthcare sidestream respiratory gas modules and…
Read the full statement (239 words)
The Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases. The Airway Gas Sampling Products are single patient use devices with a cumulative duration of use of up to 72 hours.
The Airway Gas Sampling Products include Airway Gas Sampling Sets with integrated gas sampling lines, and an Airway Adapter without sample line, both for use with compatible GE Healthcare sidestream respiratory gas modules and patient monitors utilizing these modules.
The Airway Gas Sampling Sets are provided in two sizes: large for use with adult/pediatric patients, and small for use with infant patients, for connection to the patient's breathing circuit. They are provided in two lengths: 3 meter/10 feet, and 2 meter/7 feet. The Airway Gas Sampling Sets are intended for continuous monitoring of Carbon Dioxide (CO2), Oxygen (O2), and respiratory rate in professional/hospital care environments where anesthetic agents are NOT used, such as intensive care units (ICU), emergency department (ED), coronary care unit (CCU), post anesthesia care unit (PACU) and in-hospital patient transport.
The Airway Adapter is provided in a large size for use with adult/pediatric patients, for connection to the patient's breathing circuit, and may be used with separately supplied gas sample lines. The Airway Adapter is intended for professional use environments and applications specified for the connected respiratory gas modules and patient monitors.
The Airway Gas Sampling Products are intended for use by qualified medical personnel only. Prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190824 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190824: Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190824
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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