510(k) Report

FDA applicant

Infobionic, Inc.

Lowell, MA5 decisions2014–20250 recalls

FDA records 5 decisions for Infobionic, Inc. (Lowell, MA) from 2014 to 2025: 5 510(k) clearances. Most are in product codes DSI (Detector And Alarm, Arrhythmia) and QYX (Outpatient Cardiac Telemetry). Its devices cite 8 predicates, 3 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 Infobionic, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2014: 12015: 12016: 12023: 12025: 1
2014high 1 (2014) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Infobionic, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Infobionic, 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?

  • DSIDetector And Alarm, Arrhythmia3decisions
  • QYXOutpatient Cardiac Telemetry2decisions

Whose devices does it build on?

Its devices cite 8 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 20162cite it
  • K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 20231cites it
  • K133753Mome Ecg Continuous Detection and Arrhythmia DetectorInfobionic, Inc. · 20141cites it

What has FDA decided for it lately?

  • K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc. · 2025
  • K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2023
  • K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2016
  • K152491MoMe Software PlatformInfobionic, Inc. · 2015
  • K133753Mome Ecg Continuous Detection and Arrhythmia DetectorInfobionic, Inc. · 2014

All 5 as Infobionic, Inc. →