510(k) Report

FDA applicant

Salter Labs, Division of Regulatory Affairs

Arvin, CA1 decision2008–20081 recall

FDA records 1 decision for Salter Labs, Division of Regulatory Affairs (Arvin, CA) in 2008: 1 510(k) clearance. All are in product code BZQ (Monitor, Breathing Frequency). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.

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, Division of Regulatory Affairs’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2010

2010: 1
2008high 1 (2010) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Salter Labs, Division of Regulatory Affairs by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BZQMonitor, Breathing Frequency1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K080922Salter Labs Oral/Nasal Thermal Airflow SensorSalter Labs, Division of Regulatory Affairs · 20083cite it

What has FDA decided for it lately?

  • K080922Salter Labs Oral/Nasal Thermal Airflow SensorSalter Labs, Division of Regulatory Affairs · 20081 recall

The one decision as Salter Labs, Division of Regulatory Affairs →

What has been recalled?

1 recall linked to its devices; the latest:

  • K080922ThermiSense model 5700-A5 The ThermiSense Model 5700-A5 is a nasal cannula that detects…Dec 21, 2010

Other applicant names beginning “Salter”

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

Salter Labs 50Salter Labs, Arvin Facility 1Salter Instrumentation, Inc. 1