510(k) Report

FDA applicant

Zoe Medical, Inc.

Topsfield, MA5 decisions2001–20213 recalls

FDA records 5 decisions for Zoe Medical, Inc. (Topsfield, MA) from 2001 to 2021: 5 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and MWI (Monitor, Physiological, Patient (Without…). Its devices cite 6 predicates, 1 of them its own earlier devices. 3 recalls are 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 Zoe Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2010: 12013: 12021: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2024

2009: 12012: 12024: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Zoe Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions
  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2decisions
  • DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K001775Zoe Medical Nightingale Monitoring SystemZoe Medical, Inc. · 20013cite it
  • K130740Nightingale Monitoring SystemZoe Medical, Inc. · 20132cite it
  • K040012Well@Home SystemZoe Medical, Inc. · 20041cites it

What has FDA decided for it lately?

  • K200160740 SafeSATZoe Medical, Inc. · 2021
  • K130740Nightingale Monitoring SystemZoe Medical, Inc. · 2013
  • K093802Ultraview DM3 MonitorZoe Medical, Inc. · 20102 recalls
  • K040012Well@Home SystemZoe Medical, Inc. · 20041 recall
  • K001775Zoe Medical Nightingale Monitoring SystemZoe Medical, Inc. · 2001

All 5 as Zoe Medical, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K093802Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model…Aug 13, 2024Class II
  • K093802Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is…Jun 6, 2012Class II
  • K040012The Well@Home Monitor by Patient Care technologies Model 179-2150 Intended to be used as…Feb 2, 2009