510(k) K253030
- Device
- Capnostream™35 Portable Respiratory Monitor (PM35MN)
- Applicant
- Covidien, LLC
- 510(k) number
- K253030
- Product code
- CCK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-01
- Date received
- 2025-09-19
- Regulation
- 868.1400
- Classification name
- Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Shannon Ryan
- Address
- 200 Medtronic Dr. Lafayette CO US 80026 80026
FDA Registration Numbers#
- 3035111606
- 8022032
- 2183646
- 3005767446
- 9610105
- 3010419931
- 3033959233
- 3010157426
- 3016931915
- 3010683054
- 3004415070
- 3007238566
- 1000604079
- 3006733253
- 1219324
- 1319639
- 3020460367
- 3005877899
- 3013501110
- 3009001657
- 3007695715
- 3011120183
- 3010838917
- 3015967359
- 3010390468
- 3010887638
- 3006536657
- 3023272766
- 8030229
- 3016678045
- 1423537
- 3006648320
- 3003898360
- 2529489
- 1000484830
- 3013679558
- 3029871637
- 3004906872
- 3006979678
- 3014479313
- 1526012
- 3005135175
- 3007481893
- 3009490946
- 9611031
- 3006606984
- 1066270
- 3018094310
- 1314417
- 3010223399
- 3010411911
- 3021559257
- 3006606827
- 3003263092
- 3030733800
- 3010703925
- 3008363989
- 3012834717
- 3013596024
- 3013826848
- 3017178358
- 2134752
- 3013187142
- 3009973336
- 3016852448
- 8022257
- 3003589956
- 3014579161
- 1061124
- 9610816
- 3000126629
- 3010526986
- 3001570235
- 3031158
- 3038913749
- 2023529
- 1220908
- 3012639025
- 3017844574
Source Documents#
Other 510(k) Records For Product Code CCK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251641 | GF-310R Multigas Unit (GF-310R) | Nihon Kohden Corporation | 2026-08-12 |
| K261633 | VisuBreath | Affirm Medical Technologies II, LLC | 2026-07-14 |
| K250148 | Medical Gas Analyzer (AG200) | Prior Care Science Technology, Ltd. | 2025-08-28 |
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) | Nihon Kohden Corporation | 2025-06-10 |
| K251216 | 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line | Barbaras Development, Inc. | 2025-06-04 |
| K240937 | AIM (N/A) | Inventeur, LLC | 2024-12-16 |
| K230915 | AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask | Vyaire Medical, Inc. | 2024-11-12 |
| K212425 | MicroTrend System | Exostat Medical, Inc. | 2024-11-07 |
| K222511 | Oxy2Pro | Southmedic, Inc. | 2023-11-21 |
| K213767 | Endure ETCO2/02 Nasal Cannula | Endure Industries, Inc. | 2023-09-12 |
| K221118 | CO2 Mainstream Sensor | Draegerwerk AG & CO Kgaa | 2023-04-05 |
| K210112 | XChange Device, XChange System | Pneuma Therapeutics, Inc. | 2023-01-30 |
| K220533 | Endoscopy Oxygen Mask | Engineered Medical Systems, Inc. | 2022-11-16 |
| K213911 | Microstream CO2 NanoPod | Covidien, LLC | 2022-07-29 |
| K213518 | CARESCAPE CO2 Microstream parameter | Covidien, LLC | 2022-04-12 |