Anesthesiology · 510(k) · 2026
Capnostream35 Portable Respiratory Monitor (PM35MN)
Covidien, LLC. Cleared by FDA on 1 May 2026 under submission K253030, product code CCK (analyzer, gas, carbon-dioxide, gaseous-phase). What FDA's record says, in FDA's words.
Device record · K253030
- Device. Capnostream35 Portable Respiratory Monitor (PM35MN)DEVICE
- Company. Covidien, LLCCOMPANY
- Decision. 1 May 2026, 510(k), substantially equivalent (traditional review); received 19 September 2025DECISION
- Panel. AnesthesiologyPANEL
- Product code. CCK, Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCODE
- Regulation. 21 CFR 868.1400, Class IIREG
- Source. FDA database entry · decision document (15 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Capnostream 35 monitor is a portable capnograph and pulse oximetry monitor indicated for non- invasive monitoring of carbon dioxide concentration of the expired and inspired breath (EtCO2), respiration rate (RR), arterial oxygen saturation (SpO2), and pulse rate (PR) in patient populations, including adults, pediatrics, and neonates. The Capnostream 35 monitor is indicated for use by professionally trained health care providers. The Capnostream 35 monitor is intended for use in hospitals, hospital-type facilities, intra-hospital transport, mobile emergency medical applications Medtronic Capnostream 35 Portable Respiratory Monitor Traditional 510(k) Submission 510(k) Summary Covidien llc www.medtronic.com 15 Hampshire St, Mansfield, MA 02048, USA including both ground and air transport, unless otherwise noted. Transport environments include intra- hospital transport and both ground and air emergency transport: road ambulances and rotary-wing aircraft. The Capnostream 35 monitor with Microstream capnography and accessories is indicated for continuous non-invasive monitoring of capnography-derived respiratory rate, integrated pulmonary index (IPI), apnea per hour (A/hr), and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for adult patients only. The Capnostream 35 monitor with Nellcor pulse oximeter and accessories is indicated for providing spot-check and/or continuous non-invasive […]
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsadult patients
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 12,929 reports filed against devices carrying product code CCK. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · Alaris System · CAREFUSION 303, INC. · report 2016493-2026-67352
It was reported that the device had will not calibrate. There was no patient involvement.
30 September 2026 · Malfunction · MEDLINE · Medline Industries, LP · report 1417592-2026-54142
It was reported that "The CO2 connection is breaking from the main tubing as pictured below." "We have had about 20 of them break in the last week".
30 September 2026 · Malfunction · MEDLINE · Medline Industries, LP · report 1417592-2026-54713
30 September 2026 · Malfunction · MEDLINE · Medline Industries, LP · report 1417592-2026-55279
29 September 2026 · Malfunction · Microstream · ORIDION MEDICAL · report 8044004-2026-00011
It was reported that, prior to use the device was not able to calibrate and read very low at 1 to 2 percent on CO2 calibration check. There was no patient involvement.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code CCK, in Anesthesiology, from Covidien, LLC, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.