510(k) Report

FDA applicant

Wpr Medical AS

Ne, MN1 decision2010–20100 recalls

FDA records 1 decision for Wpr Medical AS (Ne, MN) in 2010: 1 510(k) clearance. All are in product code DSI (Detector And Alarm, Arrhythmia). Its devices cite 2 predicates, 0 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 Wpr Medical AS’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Wpr Medical AS by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • DSIDetector And Alarm, Arrhythmia1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K102111Medical Magnetic Tape RecorderWpr Medical AS · 2010

The one decision as Wpr Medical AS →