Siememns Infinity ETC02 Pod
by Siemens Medical Solutions USA, Inc.
510(k) K992116
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992116 | Date12 Jan 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CCK
- Device class
- Class II
- Regulation
- 21 CFR Part 868.1400
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Infinity EtCO₂ Pod is a modular bedside monitoring accessory designed for use with Siemens SC7000/SC8000/SC9000XL series patient monitors. It measures end-tidal carbon dioxide (etCO₂), inspired carbon dioxide (iCO₂), and respiration rate via mainstream or side-stream sampling, utilizing dual-wavelength, non-dispersive infrared (NDIR) technology to analyze gas samples.
The device connects to modular monitors for data processing and is intended for use in clinical settings such as operating rooms, intensive care units, and emergency departments. Supplied as a single-use or reusable accessory (as specified by facility protocols), it requires proper calibration and maintenance per manufacturer instructions. Authorized for use in the United States under FDA 510(k) clearance (K992116), it adheres to regulatory standards for medical devices in respiratory monitoring.
Other devices from Siemens Medical Solutions USA, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of clinical environments is the Siemens Infinity EtCO₂ Pod intended for use in?
The Siemens Infinity EtCO₂ Pod is designed for use in high-acuity clinical settings where precise respiratory monitoring is critical. This includes operating rooms, intensive care units (ICUs), and emergency departments, where real-time measurement of end-tidal and inspired carbon dioxide levels is essential for patient safety and care.
How does the Siemens Infinity EtCO₂ Pod measure carbon dioxide levels, and what sampling methods does it support?
The device uses dual-wavelength, non-dispersive infrared (NDIR) technology to analyze gas samples for accurate measurement of end-tidal CO₂ (etCO₂) and inspired CO₂ (iCO₂). It supports both mainstream and side-stream sampling, allowing flexibility in how it integrates with patient ventilation circuits or breathing systems.
Is the Siemens Infinity EtCO₂ Pod a single-use or reusable device, and what considerations should facilities keep in mind?
The Siemens Infinity EtCO₂ Pod can be supplied as either single-use or reusable, depending on facility protocols. If reused, it requires proper calibration and maintenance as outlined in the manufacturer’s instructions to ensure continued accuracy and reliability. Facilities must follow their internal policies to determine the appropriate usage model.
What patient monitors is the Siemens Infinity EtCO₂ Pod compatible with, and how does it integrate with them?
The Infinity EtCO₂ Pod is a modular accessory specifically designed to connect with Siemens’ SC7000, SC8000, and SC9000XL series patient monitors. It interfaces with these monitors to process and display the measured CO₂ and respiration rate data, enabling seamless integration into existing monitoring workflows.
What regulatory pathway was followed for FDA clearance of the Siemens Infinity EtCO₂ Pod, and what does this mean for its use?
The device was cleared via the traditional 510(k) pathway under FDA clearance number K992116, with a Substantially Equivalent (SESE) determination by the Anesthesiology (AN) Advisory Committee. This means it was evaluated as comparable to a legally marketed predicate device and meets U.S. regulatory standards for respiratory monitoring, ensuring its safety and effectiveness for clinical use.