510(k) Report

510(k) · Cleared

Cleared

Dynatron STS

K010565510(k) TraditionalCleared May 15, 200178-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

Dynatronics Corp. · LIH Interferential Current Therapy

Cleared on May 15, 2001 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
May 15, 2001
Review
78 days
Class
Class II
Product code
LIH
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK010565 Dynatron STSDynatronics Corp. · 2001
  2. Descendant · cites it directly · 1 of its ownK121662 Vecttor VT-200Alan Neuromedical Technologies, LLC · 2012
  3. Descendant · 2 generations on · 0 of its ownK231575 Vecttor VT-300Artaflex, Inc. · 2024

Most influential descendants

Showing 2 of 2 · See all
  • K121662Vecttor VT-200Alan Neuromedical Technologies, LLC · 2012 · cites it directly1descendant
  • K231575Vecttor VT-300Artaflex, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010565Dynatron STSDynatronics Corp.2001—
+1K121662Vecttor VT-200Alan Neuromedical Technologies, LLC2012—
+2K231575Vecttor VT-300Artaflex, Inc.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
202410
FIG. 1 — Lineage of K010565, 2001–2024Source: 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
Get a 510(k) Report

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? (2)

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

NumberDeviceApplicantDecidedDescendants
K121662Vecttor VT-200Alan Neuromedical Technologies, LLC20121

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, K121662 (Alan Neuromedical Technologies, LLC, 2012) has gone furthest, with 1 descendant 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. “K010565: Dynatron STS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010565

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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