Home / Companies / SALTER LABS

SALTER LABS

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
49
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0796-2016Class IIT-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile pJanuary 5, 2016
Z-2781-2015Class IINebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aeAugust 4, 2015
Z-2093-2014Class IIOxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather,June 25, 2014
Z-0360-2014Class IISalter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; ManuNovember 1, 2013
Z-1898-2012Class IIAdult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CMay 30, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K190878Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuJanuary 10, 2020
K161719Salter Labs Bubble HumidifierSeptember 21, 2017
K151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with AirfloApril 15, 2016
K151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaMarch 11, 2016
K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample LinesMarch 10, 2016
K143700CPAP CannulaideAugust 5, 2015
K142416Luma WrapJune 12, 2015
K092685PNEUMOTHERML, MODEL: 5800November 24, 2009
K051313BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCERSeptember 15, 2005
K040202SALTER LABS CPAP HIGH FLOW CANNULA SYSTEMMarch 4, 2005
K014056SALTER LABS MODIFIED NEBUTECH NEBULIZERFebruary 1, 2002
K992285SALTER AIRE COMPRESSORJanuary 7, 2000
K992986SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTERSeptember 24, 1999
K991788SALTER LABS PEP DEVICEAugust 6, 1999
K990678PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)May 7, 1999
K983403SALTER LABS NEBULIZER EXHALATION AEROSOL FILTERDecember 17, 1998
K962879SALTERLABS 8660 SERIES NEBULIZEROctober 22, 1996
K962085SALTER LABS 8990 SERIES NEBULIZERAugust 26, 1996
K961476SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)July 16, 1996
K912434SALTER LABS INFANT NASAL CPAP CANNULAJuly 30, 1991