510(k) · Cleared
ClearedCO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dispo-Med (Malaysia) Sdn Bhd · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Feb 13, 2015 as substantially equivalent to K010024 (Oridion Medical 1987, Ltd., 2001) and 3 other predicates after a 105-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Feb 13, 2015
- Review
- 105 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K950387 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK950387 GeminiSpegas Industries, Ltd. · 1995
- 2 generations backK964239 Combination Oximeter/Carbon Dioxide Gas AnalyzerSpegas Industries, Ltd. · 1997
- 1 generation backK980325 Microstream Nasal Cannula FilterlineOridion Medical, Ltd. · 1998 · Recalled
- This deviceK143127 CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling…Dispo-Med (Malaysia) Sdn Bhd · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950387 | Gemini | Spegas Industries, Ltd. | 1995 | — |
| −2 | K964239 | Combination Oximeter/Carbon Dioxide Gas Analyzer | Spegas Industries, Ltd. | 1997 | — |
| −1 | K980325 | Microstream Nasal Cannula Filterline | Oridion Medical, Ltd. | 1998 | 3 |
| 0 (this device) | K143127 | CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style | Dispo-Med (Malaysia) Sdn Bhd | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K010024 | O2/CO2 Nasal FilterlineSummary page 4…CCK – CFR 868.1400 Class II Predicate Devices: O2/CO2 style devices K010024 - Oridion K011050 – Oridion CO2 sampling style devices… | 2001 |
| * | K011050 | Microstream Oral Nasal Cannula FilterlineSummary page 4…Class II Predicate Devices: O2/CO2 style devices K010024 - Oridion K011050 – Oridion CO2 sampling style devices K980325 – Oridion… | 2001 |
| * | K980325 | Microstream Nasal Cannula FilterlineSummary page 4…K010024 - Oridion K011050 – Oridion CO2 sampling style devices K980325 – Oridion K980325 – Oridion Device Description: Dispo-Med has designed a series of exhaled gas… | 1998 |
| * | K980327 | Microstream Filterline IcuSummary page 8…– Gas Sampling only style presents a comparison of the Dispo-Med Gas Sampling only style products, which provide sample expired gases like the predicates, K980325 and K980327 – Oridion Nasal gas sampling only products. The difference between the predicates is only that K980325 is designed to sample fo… | 1998 |
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 20 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 6 ancestors have a recall of any class.
- 3 other devices also cite its predicate K010024.
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. 2015, 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 Dispo-Med nasal cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases.
The Dispo-Med gas sampling lines are intended to interface with the patient via nasal cannula, nares connector, or standard sampling port connectors to the expired gas monitor.
Environment of use – hospital, sub-acute, and pre-hospital settings
Patient population – Patients requiring supplemental oxygen and / or expired gas monitoring, adult to pediatrics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143127 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143127: CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143127
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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