FDA applicant

Preventice

Rochester, MN2 decisions2012–20151 recall

FDA records 2 decisions for Preventice (Rochester, MN) from 2012 to 2015: 2 510(k) clearances. All are in product code DSI (Detector And Alarm, Arrhythmia). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.

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

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 Preventice’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2019

2012high 1 (2019) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Preventice by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Preventice”

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

Preventice Technologies, Inc. 1

Preventice

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Preventice”