Home / 510(k) Clearances / K151506

510(k) K151506

Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula by Salter Labs — Product Code NFB

K151506 is an FDA 510(k) premarket notification submitted by Salter Labs for the device "Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula". The FDA issued a decision of Substantially Equivalent on March 11, 2016. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905. Salter Labs has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2016
Date Received
June 4, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conserver, Oxygen
Device Class
Class II
Regulation Number
868.5905
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)
  • K151421 — Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannul (March 10, 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 NFB

  • K250322 — Respond OC Conserving Regulator (130-0800) (July 24, 2025)
  • K220591 — Proxima (December 15, 2022)
  • K221014 — Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile (October 17, 2022)
  • K200401 — Apogee (November 14, 2020)
  • K131023 — THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN (October 11, 2013)
  • K113111 — CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION (December 8, 2011)
  • K103392 — CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER (December 17, 2010)
  • K090421 — MODEL 350G GAS CONSERVER (May 29, 2009)
  • K070740 — CHAD THERAPEUTICS BONSAI MODEL 800 (May 7, 2007)
  • K060751 — INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR (July 18, 2006)

FDA data resources