510(k) Report

FDA applicant

Sentec AG

Egale, WI7 decisions1986–202514 recalls

FDA records 7 decisions for Sentec AG (Egale, WI) from 1986 to 2025: 7 510(k) clearances. Most are in product codes LKD (Monitor, Carbon-Dioxide, Cutaneous) and QEB (Ventilatory Electrical Impedance Tomograph). Its devices cite 19 predicates, 7 of them its own earlier devices. 14 recalls are linked to its devices.

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

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

FDA decisions per year

1in 2025

2007: 12010: 12015: 12024: 12025: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2023

2012: 32015: 12016: 12019: 52020: 12022: 12023: 2
2007high 5 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sentec AG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sentec AG’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?

  • LKDMonitor, Carbon-Dioxide, Cutaneous4decisions
  • QEBVentilatory Electrical Impedance Tomograph1decision
  • IZWCollimator, Automatic, Radiographic1decision
  • DQAOximeter1decision

Whose devices does it build on?

Its devices cite 19 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 7 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.

  • K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG · 20103cite it
  • K041548Sentec Digital Monitor Model #SDMSentec, Inc. · 20042cite it
  • K071672Sentec Digital Monitoring SystemSentec AG · 20072cite it
  • K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including…Sentec AG · 20151cites it

What has FDA decided for it lately?

  • K243765LuMon (TM) SystemSentec AG · 2025
  • K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG · 2024
  • K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including…Sentec AG · 20159 recalls
  • K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG · 201012 recalls
  • K071672Sentec Digital Monitoring SystemSentec AG · 20071 recall
  • K041548Sentec Digital Monitor Model #SDMSentec, Inc. · 20049 recalls
  • K862340Sentec Laser Guide Line, Model SGL-05Sentec Corp. · 1986

All 5 as Sentec AG →The one decision as Sentec, Inc. →The one decision as Sentec Corp. →

What has been recalled?

14 recalls linked to its devices; the latest:

  • K041548Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer…Jul 25, 2023Class II
  • K041548V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model…May 2, 2023Class II
  • K151329sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used…Aug 22, 2022Class II
  • K041548SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated…Dec 10, 2020Class II
  • K101690SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for…May 2, 2019Class II
  • K101690SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product…May 2, 2019Class II