510(k) Report

FDA applicant

Tosense, Inc.

San Diego, CA2 decisions2015–20170 recalls

FDA records 2 decisions for Tosense, Inc. (San Diego, CA) from 2015 to 2017: 2 510(k) clearances. All are in product code MWI (Monitor, Physiological, Patient (Without…). Its devices cite 5 predicates, 1 of them its own earlier devices. No 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2017

2015: 12017: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Tosense, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tosense, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142087Cova Monitoring SystemTosense, Inc. · 20151cites it

What has FDA decided for it lately?

  • K160899CoVa Monitoring System 2Tosense, Inc. · 2017
  • K142087Cova Monitoring SystemTosense, Inc. · 2015

All 2 as Tosense, Inc. →