510(k) Report

510(k) · Cleared

Cleared

Mida System, Models 1000/1100

K896396510(k) TraditionalCleared Jan 18, 199073-day reviewClass II21 CFR 870.2400

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

Medical Graphics Corp. · DYC Vectorcardiograph

Cleared on Jan 18, 1990 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
Jan 18, 1990
Review
73 days
Class
Class II
Product code
DYC
Recalls
None
Predicates
0

5 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2003: 1 descendant cleared2020: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK896396 Mida System, Models 1000/1100Medical Graphics Corp. · 1990
  2. Descendant · cites it directly · 3 of its ownK042002 Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc. · 2004
  3. Descendant · 2 generations on · 2 of its ownK193177 CER-SCardiocalm · 2020
  4. Descendant · 3 generations on · 1 of its ownK213861 CER-SCardiocalm Srl · 2022
  5. Descendant · 4 generations on · 0 of its ownK243312 CER-SCardiocalm Srl · 2025
  6. Descendant · cites it directly · 0 of its ownK023414 Mida Algorithm Rev. BOrtivus AB · 2003

Most influential descendants

Showing 5 of 5 · See all
  • K042002Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc. · 2004 · cites it directly3descendants
  • K193177CER-SCardiocalm · 2020 · 2 generations on2descendants
  • K213861CER-SCardiocalm Srl · 2022 · 3 generations on1descendant
  • K243312CER-SCardiocalm Srl · 2025 · 4 generations on0descendants
  • K023414Mida Algorithm Rev. BOrtivus AB · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K896396Mida System, Models 1000/1100Medical Graphics Corp.1990—
+1K042002Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc.2004—
+2K193177CER-SCardiocalm2020—
+3K213861CER-SCardiocalm Srl2022—
+4K243312CER-SCardiocalm Srl2025—
+1K023414Mida Algorithm Rev. BOrtivus AB2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
202010
202210
202510
FIG. 1 — Lineage of K896396, 1990–2025Source: 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.

Planning a device in DYC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • Recall history across each candidate’s familyin the report
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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? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042002Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc.20043
K023414Mida Algorithm Rev. BOrtivus AB20030

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, K042002 (Ela Medical, Inc., 2004) has gone furthest, with 3 descendants of its own.

How does its category compare?

All DYC devices

DYC Vectorcardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DYC

FDA has decided no DYC device since 2007.

Median 510(k) review, days · DYC

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

Recalls per year · DYC

No recall names DYC since 2007.

Adverse event reports per year · DYC

No MAUDE report names DYC 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 Medical Graphics Corp.

23 FDA decisions under this applicant name. See the company

  • K152585Resmon PRO FULLMedical Graphics Corp. · 2016
  • K070858Express SeriesMedical Graphics Corp. · 2007
  • K061731Medgraphics Ultima SystemMedical Graphics Corp. · 2006
  • K955432CPX, CCM, Cath with 15% CO2Medical Graphics Corp. · 1996
  • K9432591085 Ultimate E PlethysmographMedical Graphics Corp. · 1995

Recent decisions in DYC

The DYC category page

  • K023414Mida Algorithm Rev. BOrtivus AB · 2003
  • K823934Cariel F12Odam · 1983
  • K810529Direct Writing VectorcardiographElmed, Inc. · 1981

https://510kreport.com/device/K896396 · printed Nov 6, 2026

Cite this page

510(k) Report. “K896396: Mida System, Models 1000/1100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K896396

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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