510(k) Report

FDA applicant

Salter Labs

Arvin, CA50 decisions1978–20268 recalls

FDA records 50 decisions for Salter Labs (Arvin, CA) from 1978 to 2026: 50 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). Since 2016 its 510(k)s took a median of 281 days from receipt to decision, against 281 for FDA’s reviews in the same codes and years. Its devices cite 30 predicates, 14 of them its own earlier devices. 8 recalls are linked to its devices.

FDA’s records also spell it “Salter Labs, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Salter Labs’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2009: 12015: 22016: 32017: 12020: 12026 (partial year): 1
2007high 3 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2011: 42012: 12013: 12015: 12016: 1
2007high 4 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Salter Labs by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CAFNebulizer (Direct Patient Interface)9decisions
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase8decisions
  • CCLAnalyzer, Gas, Oxygen, Gaseous-Phase5decisions
  • NFBConserver, Oxygen4decisions
  • CATCannula, Nasal, Oxygen3decisions
  • BZDVentilator, Non-Continuous (Respirator)3decisions

Also: BYG (2), MNR (2), CCN (2), CCQ (2), BYF (1), BZQ (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 281 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 281 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 30 predicates; 14 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 39 times; 14 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K870027Hand Held Pheumatic Powered (Disposable) NebulizerSalter Labs · 19876cite it
  • K892406Modified Oxygen Delivery/CO2 Sample Nasal CannulaSalter Labs · 19894cite it
  • K962879Salterlabs 8660 Series NebulizerSalter Labs · 19963cite it
  • K051313BI-Naps Nasal Airflow and Snore TransducerSalter Labs · 20053cite it
  • K992285Salter Aire CompressorSalter Labs · 20003cite it
  • K863883Models 4002/4102/4202 Oxy. Delivery/CO2 CannulaSalter Labs · 19863cite it

What has FDA decided for it lately?

  • K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter Labs · 2026
  • K190878Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff…Salter Labs, Inc. · 2020
  • K161719Salter Labs Bubble HumidifierSalter Labs · 2017
  • K151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow…Salter Labs · 2016
  • K151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter Labs · 2016
  • K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample LinesSalter Labs · 2016
  • K143700CPAP CannulaideSalter Labs · 2015
  • K142416Luma WrapSalter Labs · 2015

All 49 as Salter Labs →The one decision as Salter Labs, Inc. →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K884947T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use…Jan 5, 2016Class II
  • K961476NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to…Aug 4, 2015Class II
  • K894350Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in…Nov 1, 2013Class II
  • K892406Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen…May 30, 2012Class II
  • K892406ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707…Dec 7, 2011
  • K892406Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube…Apr 19, 2011

Other applicant names beginning “Salter”

FDA records each applicant name separately; these may or may not be the same firm.

Salter Labs, Division of Regulatory Affairs 1Salter Labs, Arvin Facility 1Salter Instrumentation, Inc. 1