510(k) K212425
- Device
- MicroTrend System
- Applicant
- Exostat Medical, Inc.
- 510(k) number
- K212425
- Product code
- CCK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-11-07
- Date received
- 2021-08-04
- 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
- No
Applicant Contact#
- Contact
- Irvin Pierskalla
- Address
- 14162 Commerce Ave. NE, Suite 100 Prior Lake MN US 55372 55372
FDA Registration Numbers#
- 3010272829
- 3015272694
- 9710602
- 1423537
- 3004906872
- 3011987967
- 3003898360
- 3003674698
- 1000484830
- 3027256461
- 3014541700
- 3008716327
- 3013501110
- 3019388613
- 3003630387
- 3008363989
- 3006807694
- 3010157426
- 3017609572
- 1062836
- 3013783488
- 1319447
- 3006547005
- 3003832357
- 3011503227
- 3005587132
- 8022257
- 3009499478
- 3004977335
- 1066270
- 2023529
- 3009001657
- 3006648320
- 3015997711
- 9617604
- 3017202422
- 9616088
- 3018094310
- 8030673
- 3003879246
- 9617566
- 3004415070
- 2183646
- 3030154814
- 1319639
- 3009754460
- 3018783526
- 3003800159
- 3007695715
- 8021995
- 3016964847
- 3013652261
- 3005873568
- 3007048256
- 3003591740
- 9611500
- 3013596024
- 9710644
- 3001313714
- 3006606984
- 3013500228
- 3014479313
- 3013679558
- 9610816
- 3010149039
- 3010703925
- 3011120183
- 3010411911
- 3007238566
- 1024404
- 2134752
- 3024706751
- 3009490946
- 3010223399
- 3010419931
- 3004111573
- 3007836437
- 3005877899
- 3008483389
Source Documents#
Other 510(k) Records For Product Code CCK#
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|---|---|---|---|
| K253030 | Capnostream™35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | 2026-05-01 |
| 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 |
| 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 |
| K211171 | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories | GE Healthcare Finland Oy | 2021-10-21 |
| K203762 | Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector | Covidien | 2021-09-17 |