510(k) Report

510(k) · Cleared

Cleared

Epicardia 4000

K900207510(k) TraditionalCleared Jul 31, 1990196-day reviewClass II21 CFR 870.3260

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medicomp, Inc. · DST Clip, Vena-Cava

Cleared on Jul 31, 1990 after a 196-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 31, 1990
Review
196 days
Class
Class II
Product code
DST
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K900207Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All DST devices

DST Clip, Vena-Cava: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DST

FDA has decided no DST device since 2007.

Median 510(k) review, days · DST

Too few DST 510(k)s in any year since 2007 to give a median.

Recalls per year · DST

No recall names DST since 2007.

Adverse event reports per year · DST

No MAUDE report names DST since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Medicomp, Inc.

23 FDA decisions under this applicant name. See the company

  • 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

https://510kreport.com/device/K900207 · printed Nov 6, 2026

Cite this page

510(k) Report. “K900207: Epicardia 4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900207

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026