510(k) Report

510(k) · Cleared

Cleared

Restrospective Ecg Memory Module

K831406510(k) TraditionalCleared Jul 7, 198366-day review

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

Cardiac Evaluation Center, Inc.

Cleared on Jul 7, 1983 after a 66-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jul 7, 1983
Review
66 days
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared19801990200020102020
  1. This deviceK831406 Restrospective Ecg Memory ModuleCardiac Evaluation Center, Inc. · 1983
  2. Descendant · cites it directly · 0 of its ownK954163 Retrospective II-Elite Ecg Memory Loop RecorderCardiac Evaluation Center, Inc. · 1996

Most influential descendants

Showing 1 of 1 · See all
  • K954163Retrospective II-Elite Ecg Memory Loop RecorderCardiac Evaluation Center, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K831406Restrospective Ecg Memory ModuleCardiac Evaluation Center, Inc.1983—
+1K954163Retrospective II-Elite Ecg Memory Loop RecorderCardiac Evaluation Center, Inc.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K831406, 1983–1996Source: FDA 510(k) summaries, read by 510(k) Report · 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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K954163Retrospective II-Elite Ecg Memory Loop RecorderCardiac Evaluation Center, Inc.19960

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.

What does this lineage say?

  • Of its descendants, K954163 (Cardiac Evaluation Center, Inc., 1996) has gone furthest, with 0 descendants of its own.

More from Cardiac Evaluation Center, Inc.

2 FDA decisions under this applicant name. See the company

  • K954163Retrospective II-Elite Ecg Memory Loop RecorderCardiac Evaluation Center, Inc. · 1996

https://510kreport.com/device/K831406 · printed Nov 4, 2026

Cite this page

510(k) Report. “K831406: Restrospective Ecg Memory Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K831406

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