510(k) Report

FDA applicant

Witt Biomedical Corporation

Melbourne, FL11 decisions1988–20109 recalls

FDA records 11 decisions for Witt Biomedical Corporation (Melbourne, FL) from 1988 to 2010: 11 510(k) clearances. Most are in product codes MWI (Monitor, Physiological, Patient (Without…) and LLZ (System, Image Processing, Radiological). Its devices cite 7 predicates, 3 of them its own earlier devices. 9 recalls are linked to its devices.

FDA’s records also spell it “Witt Biomedical Corp”.

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 Witt Biomedical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 12010: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2021

2015: 12017: 32018: 32021: 1
2007high 3 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)4decisions
  • LLZSystem, Image Processing, Radiological3decisions
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)3decisions
  • DXGComputer, Diagnostic, Pre-Programmed, Single-Function1decision

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K033030Calysto Series IV Patient Care Monitors and Central Station and Ecg Management SystemWitt Biomedical Corp · 20042cite it
  • K101571Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp · 20102cite it
  • K950436Witt Biomedical Series IVWitt Biomedical Corporation · 19951cites it
  • K063840Xper Information Management/Physiomonitoring 5 System and/or Vascular 5, Patient Care Console and Central…Witt Biomedical Corp · 20071cites it

What has FDA decided for it lately?

  • K101571Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp · 20108 recalls
  • K063840Xper Information Management/Physiomonitoring 5 System and/or Vascular 5, Patient Care Console and Central…Witt Biomedical Corp · 2007
  • K063547Calysto Series IV Physio-Monitoring and Information SystemWitt Biomedical Corp · 2006
  • K040195Calysto Image IV-Image and Information Management SystemWitt Biomedical Corp · 2004
  • K033030Calysto Series IV Patient Care Monitors and Central Station and Ecg Management SystemWitt Biomedical Corp · 20041 recall
  • K010058Image IV Dicom Image Archival Pacs NetworkWitt Biomedical Corporation · 2001
  • K973474Witt Biomedical Central Station Monitoring System and Witt Biomedical Advanced Patient Care Monitoring UnitsWitt Biomedical Corporation · 1998
  • K950436Witt Biomedical Series IVWitt Biomedical Corporation · 1995

All 6 as Witt Biomedical Corporation →All 5 as Witt Biomedical Corp →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K101571Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices -…Mar 29, 2021Class II
  • K101571Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390…Nov 15, 2018Class II
  • K101571Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388Sep 24, 2018Class II
  • K101571Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388Aug 3, 2018Class II
  • K101571Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is…Nov 20, 2017Class II
  • K101571Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of…Aug 18, 2017Class II