510(k) Report

FDA applicant

Alertwatch, LLC

Ann Arbor, MI4 decisions2014–20210 recalls

FDA records 4 decisions for Alertwatch, LLC (Ann Arbor, MI) from 2014 to 2021: 4 510(k) clearances. Most are in product codes MHX (Monitor, Physiological, Patient (With…) and HGM (System, Monitoring, Perinatal). Since 2016 its 510(k)s took a median of 140 days from receipt to decision, against 227 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Alertwatch, 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 Alertwatch, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2014: 12016: 12018: 12021: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

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

Planning a device like Alertwatch, LLC’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?

  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)1decision
  • HGMSystem, Monitoring, Perinatal1decision
  • MSXSystem, Network And Communication, Physiological Monitors1decision
  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 140 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 227 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K130401Alertwatch: orAlertwatch, LLC · 20142cite it
  • K153335AlertWatch: ORAlertwatch, LLC · 20161cites it

What has FDA decided for it lately?

  • K210160AlertWatch:ACAlertwatch, Inc. · 2021
  • K173715AlertWatch:OBAlertwatch, Inc. · 2018
  • K153335AlertWatch: ORAlertwatch, LLC · 2016
  • K130401Alertwatch: orAlertwatch, LLC · 2014

All 2 as Alertwatch, LLC →All 2 as Alertwatch, Inc. →