510(k) Report

FDA applicant

Medicomp, Inc.

West Melbourne, FL23 decisions1983–20180 recalls

FDA records 23 decisions for Medicomp, Inc. (West Melbourne, FL) from 1983 to 2018: 23 510(k) clearances. Most are in product codes DSI (Detector And Alarm, Arrhythmia) and CAI (Circuit, Breathing (W Connector, Adaptor, Y…). Its devices cite 5 predicates, 5 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 Medicomp, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2009: 22016: 12018: 1
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medicomp, 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?

  • DSIDetector And Alarm, Arrhythmia7decisions
  • CAICircuit, Breathing (W Connector, Adaptor, Y Piece)2decisions
  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency2decisions
  • DQKComputer, Diagnostic, Programmable2decisions
  • DXHTransmitters And Receivers, Electrocardiograph, Telephone2decisions
  • BZAConnector, Airway (Extension)2decisions

Also: MLO (1), BYD (1), BYL (1), BZD (1), CAH (1), DST (1).

Who builds on its devices?

Later devices cite its devices 8 times; 5 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.

  • K043454Cardiopal AI with Diogenes SV (Cardiopal SV), Model PM410Medicomp, Inc. · 20052cite it
  • K830013Epi Cardia Sys. - Ambulatory MonitorMedicomp, Inc. · 19831cites it
  • K091696Savi Wireless, Model PM500Medicomp, Inc. · 20091cites it
  • K861280Medicomp Cpap Nasal CannulaMedicomp, Inc. · 19861cites it
  • K090834Epicardia 5000Medicomp, Inc. · 20091cites it
  • K851070Resp-Bac Bacteria FilterMedicomp, Inc. · 19851cites it

What has FDA decided for it lately?

  • K173170Epicardia AnywhereMedicomp, Inc. · 2018
  • K161916TelePatch Cardiac MonitorMedicomp, Inc. · 2016
  • K091696Savi Wireless, Model PM500Medicomp, Inc. · 2009
  • K090834Epicardia 5000Medicomp, Inc. · 2009
  • K043454Cardiopal AI with Diogenes SV (Cardiopal SV), Model PM410Medicomp, Inc. · 2005
  • K981119Cardiopal Model Number PM20Medicomp, Inc. · 1998
  • K952846EpicardiaMedicomp, Inc. · 1995
  • K943915Heat and Moisture Exchanger Filter (Hme)Medicomp, Inc. · 1994

All 23 as Medicomp, Inc. →