510(k) Report

510(k) · Cleared

Cleared

The Leadaway

K992372510(k) TraditionalCleared Oct 13, 199990-day reviewClass II21 CFR 890.1175

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

Therapy Equipment, Inc. · IKD Cable, Electrode

Cleared on Oct 13, 1999 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Oct 13, 1999
Review
90 days
Class
Class II
Product code
IKD
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K992372Source: 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), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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 IKD devices

IKD Cable, Electrode: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IKD

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IKD

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

Recalls per year · IKD

1in 2019

2008: 12011: 22019: 1
2007high 2 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IKD

42in 2025

2007: 32008: 42009: 52010: 22011: 22012: 32013: 42014: 32015: 32016: 572017: 332018: 52019: 42020: 72021: 122022: 172023: 72024: 102025: 42
2007high 57 (2016) · low 2 (2010)2025

MAUDE reports naming product code IKD, 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—03
20080—14
20090—05
20100—02
20110—22
20120—03
20130—04
20140—03
20150—03
20160—057
20170—033
20180—05
20190—14
20200—07
20210—012
20220—017
20230—07
20240—010
20250—042
20260—0—

What is it indicated for?

The Leadaway is to be used as a lead wire for electrotherapy devices

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

Recent decisions in IKD

The IKD category page

  • K070926Electrode/Extension Cables, Models AtarOscor, Inc. · 20072 Class I recalls
  • K935260Physiometrix Cable Adapter ModificationPhysiometrix, Inc. · 1993
  • K873361Life-Span CableChemfet Corp. · 1987
  • K834583Clear Leads-Radiotransparent WiresQuinton, Inc. · 1984
  • K800934R2 Esu Cable-Adapter Models 160,161R2 Corp. · 1980

https://510kreport.com/device/K992372 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992372: The Leadaway.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992372

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026