Home / 510(k) Clearances / K203762

510(k) K203762

Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector by Covidien — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2021
Date Received
December 23, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

Other clearances by Covidien

  • K251313 — Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with (December 29, 2025)
  • K251025 — Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, (December 29, 2025)
  • K250725 — Hugo™ RAS System (December 3, 2025)
  • K250173 — Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE T (October 6, 2025)
  • K243785 — Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye S (September 25, 2025)
  • K241486 — Sofsilk™ Coated Braided Silk Suture (December 3, 2024)
  • K240077 — Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) (August 20, 2024)
  • K241085 — Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT (July 12, 2024)
  • K240572 — Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m) (VSMP (July 1, 2024)
  • K233341 — Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, (May 20, 2024)

Other clearances for product code CCK

  • K250148 — Medical Gas Analyzer (AG200) (August 28, 2025)
  • K243956 — TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) (June 10, 2025)
  • K251216 — 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO (June 4, 2025)
  • K240937 — AIM (N/A) (December 16, 2024)
  • K230915 — AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask (November 12, 2024)
  • K212425 — MicroTrend System (November 7, 2024)
  • K222511 — Oxy2Pro (November 21, 2023)
  • K213767 — Endure ETCO2/02 Nasal Cannula (September 12, 2023)
  • K221118 — CO2 Mainstream Sensor (April 5, 2023)
  • K210112 — XChange Device, XChange System (January 30, 2023)