FDA AI Clearance Tracker/K253030
Anesthesiology · 510(k)
Capnostream35 Portable Respiratory Monitor (PM35MN)
Covidien, LLC
About this listing
Capnostream35 Portable Respiratory Monitor (PM35MN) from Covidien, LLC appears on the U.S. FDA list of AI-enabled medical devices under submission K253030. It went through the 510(k) pathway, reviewed by the Anesthesiology panel, with an FDA decision dated May 1, 2026. Its primary FDA product code is CCK.
The FDA list records the regulatory facts above. For the device's cleared intended use, read the FDA decision summary linked at the bottom of this page.
- Device
- Capnostream35 Portable Respiratory Monitor (PM35MN)
- Company
- Covidien, LLC
- Submission number
- K253030
- Pathway
- 510(k)
- Decision date
- May 1, 2026
- Specialty (lead panel)
- Anesthesiology
- Primary product code
- CCK
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Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.