510(k) · Cleared
Recalled · Class II · 2025Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oridion Medical 1987, Ltd. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Feb 8, 2019 as substantially equivalent to K980324 (Oridion Medical, Ltd., 1998) after a 249-day review. Its family tree reaches back 3 generations to 1995. It has been recalled 11 times.
- Decided
- Feb 8, 2019
- Review
- 249 days
- Class
- Class II
- Product code
- CCK
- Recalls
- 11
- Predicates
- 1
Its longest line of descent runs back 3 generations to K950387 (1995). 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 backK980324 Microstream Fillerline or/EmsOridion Medical, Ltd. · 1998 · Recalled
- This deviceK181467 Microstream Luer Adult-Pediatric Intubated Sampling Line…Oridion Medical 1987, Ltd. · 2019
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 | K980324 | Microstream Fillerline or/Ems | Oridion Medical, Ltd. | 1998 | 7 |
| 0 (this device) | K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance… | Oridion Medical 1987, Ltd. | 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 |
|---|---|---|---|
| * | K980324 | Microstream Fillerline or/EmsSummary page 4…a capnograph accessory. It is classified as follows: 21 CFR 868.1400, carbon dioxide gas analyzer. This device is classified identically to the cleared predicate device K980324 and K980327 (reference device). Page 1 === Page 5… | 1998 |
| † | K980327 | Microstream Filterline Icu | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 7, 2025 | Class II | Z-1722-2025 | Unknown/Undetermined by firm | Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible. |
| Feb 17, 2025 | Class II | Z-1380-2025 | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g.… |
| Feb 17, 2025 | Class II | Z-1377-2025 | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g.… |
| Feb 17, 2025 | Class II | Z-1385-2025 | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g.… |
| Feb 17, 2025 | Class II | Z-1376-2025 | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g.… |
| Feb 17, 2025 | Class II | Z-1381-2025 | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g.… |
| Feb 17, 2025 | Class II | Z-1379-2025 | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g.… |
| Feb 17, 2025 | Class II | Z-1382-2025 | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g.… |
| Feb 17, 2025 | Class II | Z-1383-2025 | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g.… |
| Feb 17, 2025 | Class II | Z-1384-2025 | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g.… |
| Feb 17, 2025 | Class II | Z-1378-2025 | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g.… |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
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?
Intended to conduct a sample of the patient's breathing from a ventilator or anesthesia machine to a gas measurement device for measuring the percentage of CO2 in the patient's exhaled breath. The set is intended for single patient use only. Intended population: Intubated Adult- Pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181467 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181467: Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181467
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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