Data / Medical devices / United States / Salter Labs
Salter Labs: FDA-registered device maker in El Paso, TX, United States, 45 510(k) clearances
Salter Labs is registered with the FDA (registration 3004748541) in El Paso, TX, United States. It lists 34 device types. The FDA files 45 510(k) clearances under its listings, the newest dated July 30, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004748541
- Address
- 30 Spur Drive, El Paso, TX, United States, 79906
- Owner or operator
- SunMed "also trading as AirLife" (9038422)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 21, 1992
- Registered through
- 2027
- Brand names listed
- ACCU-FLOW Venturi Oxygen System, Aloha, Aspen, Bravo, CO2 Comfort Soft Plus Cannula, CPAP Cannulaide®, Cannula, Nasal, Oxygen, with E-Z wraps, Capnovue and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 30, 2026 | K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | CCL | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| January 10, 2020 | K190878 | Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff | BTR | Substantially Equivalent | Salter Labs, Inc. | accessdata.fda.gov |
| September 21, 2017 | K161719 | Salter Labs Bubble Humidifier | BTT | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| December 14, 2016 | K162343 | Westmed Gas Sampling Cannula with O2 delivery | CCK | Substantially Equivalent | Westmed, Inc. | accessdata.fda.gov |
| April 15, 2016 | K151874 | BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal | MNR | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| March 11, 2016 | K151506 | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula | NFB | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| March 10, 2016 | K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines | CCK | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| August 5, 2015 | K143700 | CPAP Cannulaide | BZD | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| June 12, 2015 | K142416 | Luma Wrap | PDH | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| December 31, 2013 | K133806 | M1 CAPNOGRAPHY MASK | CCK | Substantially Equivalent | Monitor Mask, Inc. | accessdata.fda.gov |
| March 28, 2013 | K121743 | EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN | BXN | Substantially Equivalent | Sunmed, LLC | accessdata.fda.gov |
| February 10, 2012 | K113542 | SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) | BTT | Substantially Equivalent | Salter Labs, Arvin Facility | accessdata.fda.gov |
| June 3, 2010 | K100546 | PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE | BTR | Substantially Equivalent | Parkermedicalinc | accessdata.fda.gov |
| March 11, 2010 | K092886 | WELL LEAD ENDOBRONCHIAL TUBES | CBI | Substantially Equivalent | Well Lead Instruments | accessdata.fda.gov |
| November 24, 2009 | K092685 | PNEUMOTHERML, MODEL: 5800 | BZQ | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| December 19, 2008 | K082630 | VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES | DXQ | Substantially Equivalent | Zefon Intl. | accessdata.fda.gov |
| June 9, 2008 | K080366 | DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES | DXQ | Substantially Equivalent | Zefon Intl. | accessdata.fda.gov |
| August 17, 2006 | K062224 | RESPCARE HYBRID AV MASK | BZD | Substantially Equivalent | Respcare, Inc. | accessdata.fda.gov |
| August 17, 2006 | K062019 | RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD | CBK | Substantially Equivalent | Innomed Technologies, Inc./Respcare, Inc. | accessdata.fda.gov |
| December 7, 2005 | K052249 | UTOPIA | BZD | Substantially Equivalent | Respcare, Inc. | accessdata.fda.gov |
| October 28, 2005 | K052227 | RESPCARE FACE MASK | BZD | Substantially Equivalent | Respcare, Inc. | accessdata.fda.gov |
| May 4, 2005 | K050171 | IT NASAL MASK | BZD | Substantially Equivalent | Innomed Technologies | accessdata.fda.gov |
| February 16, 2005 | K050104 | APEX MEDICAL MININEB & MINIPLUS | CAF | Substantially Equivalent | Apex Medical Corp. | accessdata.fda.gov |
| January 14, 2004 | K031896 | NASAL-AIR CRITICAL CARE | MNS | Substantially Equivalent | Innomed Technologies | accessdata.fda.gov |
| March 21, 2003 | K022465 | MODIFICATION TO NASAL-AIRE | BZD | Substantially Equivalent | Innomed Technologies | accessdata.fda.gov |
| January 7, 2000 | K992285 | SALTER AIRE COMPRESSOR | CAF | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| November 26, 1999 | K990659 | NASAL AIRE | BZD | Substantially Equivalent | Breathing Technologies Corp. | accessdata.fda.gov |
| September 24, 1999 | K992986 | SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER | CAF | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| August 6, 1999 | K991788 | SALTER LABS PEP DEVICE | CAF | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| July 15, 1999 | K984528 | PARKER FLEX-TIP TRACHEAL TUBE | BTR | Substantially Equivalent | Parker Medical Assoc. | accessdata.fda.gov |
| April 2, 1999 | K983467 | THERAPEP | BWF | Substantially Equivalent | Dhd Healthcare Corp. | accessdata.fda.gov |
| December 17, 1998 | K983403 | SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER | CAF | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| October 22, 1996 | K962879 | SALTERLABS 8660 SERIES NEBULIZER | CAF | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| July 16, 1996 | K961476 | SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984) | CAF | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| March 29, 1996 | K952713 | MINI WRIGHT LR AFS | BZH | Substantially Equivalent | Clement Clarke, Inc. | accessdata.fda.gov |
| July 2, 1993 | K930957 | ZEFON GAS SAMPLING LINES | CCK | Unknown | Zefon Medical Products | accessdata.fda.gov |
| July 23, 1992 | K921997 | CUFF-M | DXQ | Substantially Equivalent | Lorin Medical, Inc. | accessdata.fda.gov |
| October 18, 1991 | K913421 | NASAL OXYGEN CANNULA, 81585, 81587 & 81589 | CAT | Substantially Equivalent | Specialty Packaging Producs, Inc. | accessdata.fda.gov |
| July 24, 1991 | K911740 | SALTER LABS NEONATAL NASAL OXYGEN CANNULA | CAT | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| July 19, 1991 | K912633 | SALTER LABS INFANT MEDIUM CONCENTRATION MASK | BYG | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| December 17, 1990 | K903539 | SALTER LABS MODEL #1015 | CBH | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| March 16, 1987 | K870027 | HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER | CCQ | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| October 6, 1986 | K863656 | SALTER VOLUCHEK 6600 | BZG | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| September 18, 1986 | K863432 | OXYGEN CANNULA EAR WRAP (STYLE B) | CAT | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| January 3, 1978 | K772127 | OXYGEN MASK, AIR-ENTRAINMENT | BYF | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
Compare with other makers
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Updated July 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.