510(k) · Cleared
Recalled · Class I · 2014Datex-Ohmeda S/5 Single-Width Airway Module, E-Minic and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Oct 14, 2005 as substantially equivalent to K023454 (Datex-Ohmeda, 2003) after a 24-day review. Its family tree reaches back 2 generations to 2000. 1 of the 3 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Oct 14, 2005
- Review
- 24 days
- Class
- Class II
- Product code
- CCK
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001814 (2000). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK001814 Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01)…Datex-Ohmeda · 2000
- 1 generation backK023454 Datex-Ohmeda S/5 Single-Width Airway Module M-Minic and AccessoriesDatex-Ohmeda · 2003
- This deviceK052582 Datex-Ohmeda S/5 Single-Width Airway Module, E-Minic and AccessoriesGE Healthcare · 2005
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 | K023454 | Datex-Ohmeda S/5 Single-Width Airway Module M-Minic and Accessories | Datex-Ohmeda | 2003 | — |
| 0 (this device) | K052582 | Datex-Ohmeda S/5 Single-Width Airway Module, E-Minic and Accessories | GE Healthcare | 2005 | — |
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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K023454 | Datex-Ohmeda S/5 Single-Width Airway Module M-Minic and AccessoriesSummary page 1…le, E-miniC is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda Single-width airway module, M-miniC (K023454). Page 2 of 3… | 2003 |
| † | K043276 | Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec Module | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 11, 2014 | Class I | Z-2068-2014 | Device Design | Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous decrease of measured Et-/FiCO2 values. Incorrect Et CO2/Fi CO2 value may impair clinical decision making for both mechanically and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K023454.
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 Datex-Ohmeda S/5 Single-width airway module, E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients. E-miniC is indicated for monitoring patients weighing more than 5kg (11 lbs.).
The device is indicated for use by qualified medical personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052582: Datex-Ohmeda S/5 Single-Width Airway Module, E-Minic and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052582
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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