510(k) Report

510(k) · Cleared

Cleared

Matrix Pro-Elecdt

K930263510(k) TraditionalCleared Jun 9, 1994506-day reviewClass II21 CFR 882.5890

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

Matrix Electromedical, Inc. · LIH Interferential Current Therapy

Cleared on Jun 9, 1994 after a 506-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Jun 9, 1994
Review
506 days
Class
Class II
Product code
LIH
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared1990200020102020
  1. This deviceK930263 Matrix Pro-ElecdtMatrix Electromedical, Inc. · 1994
  2. Descendant · cites it directly · 0 of its ownK022433 Neogenesys 2KSanexas Intl. GmbH · 2003

Most influential descendants

Showing 1 of 1 · See all
  • K022433Neogenesys 2KSanexas Intl. GmbH · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930263Matrix Pro-ElecdtMatrix Electromedical, Inc.1994—
+1K022433Neogenesys 2KSanexas Intl. GmbH2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K930263, 1994–2003Source: 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 LIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LIH device

  1. #1 K231575 Vecttor VT-300score 7.1 · 2 generations · no Class I recall
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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
K022433Neogenesys 2KSanexas Intl. GmbH20030

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, K022433 (Sanexas Intl. GmbH, 2003) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LIH devices

LIH Interferential Current Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LIH

1in 2024

2007: 12009: 22010: 22011: 12012: 22019: 12021: 12024: 1
2007high 2 (2009) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIH

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

Recalls per year · LIH

No recall names LIH since 2007.

Adverse event reports per year · LIH

1in 2025

2008: 142009: 32010: 22011: 12012: 12013: 12015: 12016: 12017: 12019: 12021: 12024: 12025: 1
2007high 14 (2008) · low 0 (2007)2025

MAUDE reports naming product code LIH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—014
20092—03
20102—02
20111—01
20122—01
20130—01
20140—00
20150—01
20160—01
20170—01
20180—00
20191—01
20200—00
20211—01
20220—00
20230—00
20241—01
20250—01
20260—0—
Cite this page

510(k) Report. “K930263: Matrix Pro-Elecdt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930263

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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