510(k) Report

FDA applicant

Phillips Medical Systems

Andover, MA4 decisions2004–20151 recall

FDA records 4 decisions for Phillips Medical Systems (Andover, MA) from 2004 to 2015: 4 510(k) clearances. Most are in product codes DSJ (Alarm, Blood-Pressure) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 7 predicates, 0 of them its own earlier devices. 1 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 Phillips Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2008: 12011: 12015: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Phillips Medical Systems’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?

  • DSJAlarm, Blood-Pressure1decision
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)1decision
  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 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.

  • K103646Intellivue MX40 Patient MonitorPhillips Medical Systems · 20113cite it
  • K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems · 20152cite it

What has FDA decided for it lately?

  • K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems · 2015
  • K103646Intellivue MX40 Patient MonitorPhillips Medical Systems · 20111 recall
  • K080548HD7 Diagnostic Ultrasound SystemPhillips Medical Systems · 2008
  • K041942M2376A Devicelink SystemPhillips Medical Systems · 2004

All 4 as Phillips Medical Systems →

What has been recalled?

1 recall linked to its devices; the latest:

  • K103646IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information…May 22, 2014Class II

Other applicant names beginning “Phillips”

FDA records each applicant name separately; these may or may not be the same firm.

Phillips Medical Systems (Cleveland), Inc. 1Phillips Pharmaceuticals, Inc. 1