510(k) · Cleared
Recalled · Class II · 2019Medley ETCO2 Module (Includes Accessories), Model 8300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alaris Medical Systems, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Feb 9, 2004 as substantially equivalent to K964239 (Spegas Industries, Ltd., 1997) after a 250-day review. Its family tree reaches back 2 generations to 1995. It has been recalled 2 times.
- Decided
- Feb 9, 2004
- Review
- 250 days
- Class
- Class II
- Product code
- CCK
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950387 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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…n Rate (RR) on patients in the operating room, ICU, NICU, transport and emergency treatment. This capnograph technology originates from the MediCap/NPB-75 (K964239). The current 0 05 53 === Page 2… | 1997 |
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 |
|---|---|---|---|---|
| Jul 1, 2019 | Class II | Z-2443-2019 | Employee error | Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2 |
| Nov 12, 2015 | Class II | Z-0455-2016 | Other | CareFusion is recalling the Alaris EtCO2 module model 8300 because it may have been tested during service using a higher than specified concentration of CO2. The effect to the EtCO2 module tested with a higher concentration of CO2 could… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- None of the 2 ancestors has a recall.
- 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 Medley EtCO 2 Module is a capnograph that continuously monitors end tidal carbon dioxide (EtCO2 ), fractional inspired carbon dioxide (FiCO 2 ), and respiratory rate (RR). The monitor is intended for use by professional healthcare providers where continuous, non-invasive monitoring of these parameters is desired.
The MedleyT' EtCO 2 Module is indicated for use on adults, pediatrics and infant/neonates for both intubated and non-intubated patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031741 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031741: Medley ETCO2 Module (Includes Accessories), Model 8300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031741
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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