Home / 510(k) Clearances / K151421

510(k) K151421

Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines by Salter Labs — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2016
Date Received
May 28, 2015
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 Salter Labs

  • K190878 — Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-T (January 10, 2020)
  • K161719 — Salter Labs Bubble Humidifier (September 21, 2017)
  • K151874 — BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlo (April 15, 2016)
  • K151506 — Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula (March 11, 2016)
  • K143700 — CPAP Cannulaide (August 5, 2015)
  • K142416 — Luma Wrap (June 12, 2015)
  • K092685 — PNEUMOTHERML, MODEL: 5800 (November 24, 2009)
  • K051313 — BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER (September 15, 2005)
  • K040202 — SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM (March 4, 2005)
  • K014056 — SALTER LABS MODIFIED NEBUTECH NEBULIZER (February 1, 2002)

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)