Salter Labs
FDA Regulatory Profile
Salter Labs appears in FDA public data with 5 recalls, 49 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0796-2016, Class II) was initiated on January 5, 2016. Its most recent 510(k) clearance was granted on January 10, 2020.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 49
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0796-2016 | Class II | T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile p | January 5, 2016 |
| Z-2781-2015 | Class II | NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate ae | August 4, 2015 |
| Z-2093-2014 | Class II | Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, | June 25, 2014 |
| Z-0360-2014 | Class II | Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manu | November 1, 2013 |
| Z-1898-2012 | Class II | Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. C | May 30, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K190878 | Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCu | January 10, 2020 |
| K161719 | Salter Labs Bubble Humidifier | September 21, 2017 |
| K151874 | BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with 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 Cannula, Sample Lines | 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 |
| K992285 | SALTER AIRE COMPRESSOR | January 7, 2000 |
| K992986 | SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER | September 24, 1999 |
| K991788 | SALTER LABS PEP DEVICE | August 6, 1999 |
| K990678 | PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC) | May 7, 1999 |
| K983403 | SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER | December 17, 1998 |
| K962879 | SALTERLABS 8660 SERIES NEBULIZER | October 22, 1996 |
| K962085 | SALTER LABS 8990 SERIES NEBULIZER | August 26, 1996 |
| K961476 | SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984) | July 16, 1996 |
| K912434 | SALTER LABS INFANT NASAL CPAP CANNULA | July 30, 1991 |