# Alertwatch, LLC

- Location (FDA's records): Ann Arbor, MI
- FDA decisions: 4 (2014–2021): 4 510(k) clearances
- Names in FDA's records: Alertwatch, LLC (2); Alertwatch, Inc. (2)
- Product codes: MHX (1), HGM (1), MSX (1), MWI (1)
- 510(k) review time since 2016: median 140 days, against 227 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 3 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN: 1 (https://510kreport.com/company/philips-medizinsysteme-boeblingen-cardiac-an)
- Visicu, Inc.: 1 (https://510kreport.com/company/visicu)

## Firms that cite its devices most
- Decisio Health, Inc.: 1 (https://510kreport.com/company/decisio-health)

## Its most-cited devices
- K130401: Alertwatch: or (2014), cited by 2
- K153335: AlertWatch: OR (2016), cited by 1

## Recent decisions
- K210160: AlertWatch:AC (Sep 10, 2021)
- K173715: AlertWatch:OB (Apr 23, 2018)
- K153335: AlertWatch: OR (Mar 15, 2016)
- K130401: Alertwatch: or (Feb 7, 2014)

Source page: https://510kreport.com/company/alertwatch