510(k) Report

FDA applicant

Redsense Medical AB

Fridley, MN4 decisions2007–20130 recalls

FDA records 4 decisions for Redsense Medical AB (Fridley, MN) from 2007 to 2013: 4 510(k) clearances. All are in product code ODX (Autonomous Extracorporeal Blood Leak…). Its devices cite 9 predicates, 6 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, gastroenterology and urology panel, where it files most

How often FDA has decided Redsense Medical AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 12010: 12011: 12013: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Redsense Medical AB 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?

  • ODXAutonomous Extracorporeal Blood Leak Detector/Alarm4decisions

Whose devices does it build on?

Its devices cite 9 predicates; 6 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.

  • K071013RedsenseRedsense Medical AB · 20073cite it
  • K092955Redsense-Home UseRedsense Medical AB · 20102cite it
  • K103242Redsense-Alarm Unit and SensorRedsense Medical AB · 20111cites it

What has FDA decided for it lately?

  • K130554Redsense Alarm SystemRedsense Medical AB · 2013
  • K103242Redsense-Alarm Unit and SensorRedsense Medical AB · 2011
  • K092955Redsense-Home UseRedsense Medical AB · 2010
  • K071013RedsenseRedsense Medical AB · 2007

All 4 as Redsense Medical AB →