510(k) Report

FDA applicant

Zymed Medical Instrumentation

Camarillo, CA7 decisions1993–20000 recalls

FDA records 7 decisions for Zymed Medical Instrumentation (Camarillo, CA) from 1993 to 2000: 7 510(k) clearances. Most are in product codes DSI (Detector And Alarm, Arrhythmia) and MLO (Electrocardiograph, Ambulatory, With Analysis…). Its devices cite 4 predicates, 2 of them its own earlier devices. No 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 Zymed Medical Instrumentation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zymed Medical Instrumentation since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Zymed Medical Instrumentation’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?

  • DSIDetector And Alarm, Arrhythmia2decisions
  • MLOElectrocardiograph, Ambulatory, With Analysis Algorithm2decisions
  • DSHRecorder, Magnetic Tape, Medical1decision
  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision
  • DQKComputer, Diagnostic, Programmable1decision

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 13 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.

  • K955015Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 19965cite it
  • K990170Holter 2000Zymed Medical Instrumentation · 19994cite it
  • K951370Zymed Telemetry System; Model T8010Zymed Medical Instrumentation · 19952cite it
  • K930894Multitrak-PlusZymed Medical Instrumentation · 19931cites it
  • K984089Zymed Telemetry System, Model Easi ViewZymed Medical Instrumentation · 19991cites it

What has FDA decided for it lately?

  • K002004ZYBITZymed Medical Instrumentation · 2000
  • K992197Modification to Zymed Holter 2000Zymed Medical Instrumentation · 1999
  • K990170Holter 2000Zymed Medical Instrumentation · 1999
  • K984089Zymed Telemetry System, Model Easi ViewZymed Medical Instrumentation · 1999
  • K955015Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
  • K951370Zymed Telemetry System; Model T8010Zymed Medical Instrumentation · 1995
  • K930894Multitrak-PlusZymed Medical Instrumentation · 1993

All 7 as Zymed Medical Instrumentation →