510(k) · Cleared
ClearedSiememns Infinity ETC02 Pod
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Jan 12, 2000 as substantially equivalent to K954632 (Siemens Medical Solutions USA, Inc., 1996) and 1 other predicate after a 204-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jan 12, 2000
- Review
- 204 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K954632 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK954632 Siemens SC 9000 ETCO2 ModuleSiemens Medical Solutions USA, Inc. · 1996
- This deviceK992116 Siememns Infinity ETC02 PodSiemens Medical Solutions USA, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954632 | Siemens SC 9000 ETCO2 Module | Siemens Medical Solutions USA, Inc. | 1996 | — |
| 0 (this device) | K992116 | Siememns Infinity ETC02 Pod | Siemens Medical Solutions USA, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (2)
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 |
|---|---|---|---|
| * | K954632 | Siemens SC 9000 ETCO2 ModuleSummary page 1…i Number Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 73CCK I 868.1400 3. Predicate Device Identification: Siemens SC9000 etCO2 Module Novametrix CO2SMO Plus 510(k) K954632 510(k) K963380 4. Device Description: The INFINITY etCO2 Pod is an addition to Siemens SC8000/SC7000/SC3000XL INFINITY modular b… | 1996 |
| * | K963380 | CO 2 Smo PlusSummary page 1…zer, Gas, Carbon-Dioxide, Gaseous-Phase | 73CCK I 868.1400 3. Predicate Device Identification: Siemens SC9000 etCO2 Module Novametrix CO2SMO Plus 510(k) K954632 510(k) K963380 4. Device Description: The INFINITY etCO2 Pod is an addition to Siemens SC8000/SC7000/SC3000XL INFINITY modular bedside monitori… | 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K954632.
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?
Siemens INFINITY etCO2 is indicated for use in the adult, pediatric and neonatal populations, in an environment where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required to measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode (side-stream mode is not intended for use in the neonatal patient population). In conjunction with the SC 7000 / SC 8000 / SC 9000XL monitors, visual and audible alarms will be produced if any of these parameters vary beyond preset limits, and timed or alarm recordings will be produced.
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/K992116 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992116: Siememns Infinity ETC02 Pod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992116
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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