# Salter Labs

- Location (FDA's records): Arvin, CA
- FDA decisions: 50 (1978–2026): 50 510(k) clearances
- Names in FDA's records: Salter Labs (49); Salter Labs, Inc. (1)
- Product codes: CAF (9), CCK (8), CCL (5), NFB (4), CAT (3), BZD (3), BYG (2), MNR (2), CCN (2), CCQ (2), BYF (1), BZQ (1)
- 510(k) review time since 2016: median 281 days, against 281 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 30 (14 its own); citations of its devices by later devices: 39 (14 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Salter Labs, Division of Regulatory Affairs: 2 (https://510kreport.com/company/salter-labs-division-of-regulatory-affairs)
- Medical Industries America, Inc.: 2 (https://510kreport.com/company/medical-industries-america)
- Respironics, Inc.: 2 (https://510kreport.com/company/respironics)
- Pari Holding Co.: 1 (https://510kreport.com/company/pari-holding)
- Instrumentation Industries, Inc.: 1 (https://510kreport.com/company/instrumentation-industries)
- Mercury Medical: 1 (https://510kreport.com/company/mercury-medical)
- Bionix Development Corp.: 1 (https://510kreport.com/company/bionix-development)
- Pro-Tech Services, Inc.: 1 (https://510kreport.com/company/pro-tech-services)

## Firms that cite its devices most
- Oridion Medical 1987, Ltd.: 3 (https://510kreport.com/company/oridion-medical-1987)
- Care Fusion: 3 (https://510kreport.com/company/care-fusion)
- Med2000 S.R.L.: 2 (https://510kreport.com/company/med2000)
- Flaem Nuova S.P.A.: 2 (https://510kreport.com/company/flaem-nuova)
- 3A Health Care S.R.L.: 2 (https://510kreport.com/company/3a-health-care)
- Hudson Respiratory Care, Inc.: 2 (https://510kreport.com/company/hudson-respiratory-care)
- Tylenol Medical Instruments Co., Ltd.: 1 (https://510kreport.com/company/tylenol-medical-instruments)
- Ventus Medical, Inc.: 1 (https://510kreport.com/company/ventus-medical)

## Its most-cited devices
- K870027: Hand Held Pheumatic Powered (Disposable) Nebulizer (1987), cited by 6
- K892406: Modified Oxygen Delivery/CO2 Sample Nasal Cannula (1989), cited by 4
- K962879: Salterlabs 8660 Series Nebulizer (1996), cited by 3
- K051313: BI-Naps Nasal Airflow and Snore Transducer (2005), cited by 3
- K992285: Salter Aire Compressor (2000), cited by 3
- K863883: Models 4002/4102/4202 Oxy. Delivery/CO2 Cannula (1986), cited by 3

## Recent decisions
- K261389: PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) (Jul 30, 2026)
- 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 (Jan 10, 2020)
- K161719: Salter Labs Bubble Humidifier (Sep 21, 2017)
- K151874: BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal (Apr 15, 2016)
- K151506: Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula (Mar 11, 2016)
- K151421: Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines (Mar 10, 2016)
- K143700: CPAP Cannulaide (Aug 5, 2015)
- K142416: Luma Wrap (Jun 12, 2015)

Source page: https://510kreport.com/company/salter-labs