510(k) · Cleared
Recalled · Class II · 2025Microstream Fillerline or/Ems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oridion Medical, Ltd. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Apr 16, 1998 as substantially equivalent to K964239 (Spegas Industries, Ltd., 1997) after a 78-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it. It has been recalled 7 times.
- Decided
- Apr 16, 1998
- Review
- 78 days
- Class
- Class II
- Product code
- CCK
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950387 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK950387 GeminiSpegas Industries, Ltd. · 1995
- 1 generation backK964239 Combination Oximeter/Carbon Dioxide Gas AnalyzerSpegas Industries, Ltd. · 1997
- This deviceK980324 Microstream Fillerline or/EmsOridion Medical, Ltd. · 1998
- Descendant · cites it directly · 0 of its ownK181467 Microstream Luer Adult-Pediatric Intubated Sampling Line…Oridion Medical 1987, Ltd. · 2019 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K181467Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance…Oridion Medical 1987, Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950387 | Gemini | Spegas Industries, Ltd. | 1995 | — |
| −1 | K964239 | Combination Oximeter/Carbon Dioxide Gas Analyzer | Spegas Industries, Ltd. | 1997 | — |
| 0 (this device) | K980324 | Microstream Fillerline or/Ems | Oridion Medical, Ltd. | 1998 | — |
| +1 | K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance… | Oridion Medical 1987, Ltd. | 2019 | 11 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K964239 | Combination Oximeter/Carbon Dioxide Gas AnalyzerSummary page 1…RM 2892: A 733250 5.5. PRODUCT CLASSIFICATION The Microstream Filterline OR/EMS sample line has not been classified. It was included as an accessory in FDA submission K964239. We believe that it falls under 21CFR868 anesthesiology devices. 5.6. INTENDED USE: The intended use of the Microstream Filterli… | 1997 |
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 |
|---|---|---|---|
| K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance… | 2019 | 0 |
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 16, 2012 | Not classified | Z-1333-2012 | Packaging process control | CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification. |
| Feb 16, 2012 | Not classified | Z-1334-2012 | Packaging process control | CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification. |
| Feb 16, 2012 | Not classified | Z-1332-2012 | Packaging process control | CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification. |
| Dec 1, 2011 | Not classified | Z-1349-2012 | Device Design | Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet |
| May 26, 2010 | Not classified | Z-2010-2010 | Process design | The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment. |
| May 26, 2010 | Not classified | Z-2012-2010 | Process design | The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment. |
The 5 latest of 7 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 3 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K181467 (Oridion Medical 1987, Ltd., 2019) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K964239.
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.
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 MICROSTREAM FILTERLINE OR/EMS DEVICE IS USED WHENEVER THE PHYSICIAN NEEDS TO MEASURE THE CO; IN AN INTUBATED PATIENT'S BREATHING.
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/K980324 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980324: Microstream Fillerline or/Ems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980324
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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