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510(k) K912174

SALTER LABS DISPOSABLE NIPPLE AND NUT by Salter Labs — Product Code CAN

K912174 is an FDA 510(k) premarket notification submitted by Salter Labs for the device "SALTER LABS DISPOSABLE NIPPLE AND NUT". The FDA issued a decision of Substantially Equivalent on July 24, 1991. The device falls under product code CAN (Regulator, Pressure, Gas Cylinder), a Class I device regulated under 21 CFR 868.2700. Salter Labs has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1991
Date Received
May 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Pressure, Gas Cylinder
Device Class
Class I
Regulation Number
868.2700
Review Panel
AN
Submission Type

Other clearances by Salter Labs

  • K261389 — PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) (July 30, 2026)
  • 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)
  • 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)

Other clearances for product code CAN

  • K162811 — MR Conditional CGA 870 (March 2, 2017)
  • K080243 — PORTABLE OXYGEN UNIT SCA900 (April 7, 2009)
  • K060265 — REMCORE REMOTE CONTROLLED OXYGEN REGULATOR (October 25, 2006)
  • K061785 — CYL-FIL OXYGEN SYSTEM (September 7, 2006)
  • K950777 — OXYGEN REGULATOR (April 14, 1995)
  • K942751 — VANGUARD SERIES GAS REGULATORS (February 9, 1995)
  • K936187 — LSPI PRESSURE REGULATOR (January 27, 1994)
  • K932006 — 1500 SERIES REGULATOR (October 25, 1993)
  • K921125 — AMBU OXYGEN REGULATOR (September 17, 1992)
  • K915154 — GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS (May 27, 1992)

FDA data resources