510(k) Report

510(k) · Cleared

Cleared

Model 6984M Lead Extender Kit

K915724510(k) TraditionalCleared Feb 18, 199260-day reviewClass II21 CFR 870.3620

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

Medtronic Vascular · DTD Pacemaker Lead Adaptor

Cleared on Feb 18, 1992 after a 60-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
Feb 18, 1992
Review
60 days
Class
Class II
Product code
DTD
Recalls
None
Predicates
0

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

Descendants, by year cleared 2013: 1 descendant cleared1990200020102020
  1. This deviceK915724 Model 6984M Lead Extender KitMedtronic Vascular · 1992
  2. Descendant · cites it directly · 0 of its ownK132008 6981M Lead Extender Kit, 6984M Lead Extender Kit, 6986M Lead…Medtronic, Inc. · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K1320086981M Lead Extender Kit, 6984M Lead Extender Kit, 6986M Lead Extender Kit, 5866-24M Lead…Medtronic, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K915724Model 6984M Lead Extender KitMedtronic Vascular1992—
+1K1320086981M Lead Extender Kit, 6984M Lead Extender Kit, 6986M Lead Extender Kit…Medtronic, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K915724, 1992–2013Source: 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 DTD? 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 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
K1320086981M Lead Extender Kit, 6984M Lead Extender Kit, 6986M Lead Extender Kit, 5866-24M Lead…Medtronic, Inc.20130

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, K132008 (Medtronic, Inc., 2013) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DTD devices

DTD Pacemaker Lead Adaptor: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTD

1in 2015

2013: 12015: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTD

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

Recalls per year · DTD

No recall names DTD since 2007.

Adverse event reports per year · DTD

32in 2025

2007: 82008: 82009: 82010: 362011: 182012: 192013: 302014: 212015: 412016: 202017: 162018: 292019: 342020: 192021: 232022: 252023: 282024: 352025: 32
2007high 41 (2015) · low 8 (2007)2025

MAUDE reports naming product code DTD, 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
20070—08
20080—08
20090—08
20100—036
20110—018
20120—019
20131—030
20140—021
20151—041
20160—020
20170—016
20180—029
20190—034
20200—019
20210—023
20220—025
20230—028
20240—035
20250—032
20260—0—

More from Medtronic Vascular

1,057 FDA decisions under this applicant name. See the company

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  • P160043/S095Resolute Onyx Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular · 2026
  • P160043/S094Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent…Medtronic Vascular · 2026
  • P160043/S093Resolute Onyx Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular · 2026
  • P160043/S092Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent…Medtronic Vascular · 2026

Recent decisions in DTD

The DTD category page

  • K143463IS4/DF4 Port PlugOscor, Inc. · 2015
  • K1320086981M Lead Extender Kit, 6984M Lead Extender Kit, 6986M Lead Extender Kit, 5866-24M Lead Adaptor Kit…Medtronic, Inc. · 2013
  • K041574Cpi Lead Adapters, Models 6017, 6018 and 6020Guidant Corporation · 2004
  • K031164Pacing Lead Adaptors, Bipolar, Models Ilink-Bis, Ilink-BLVOscor, Inc. · 2003
  • K024156Pacing Lead Extensions, Bipolar, Pacing Lead Adaptors, Unipolar/Bipolar,Pacing Lead Adaptors, Unipolar/BipolarOscor, Inc. · 2003

https://510kreport.com/device/K915724 · printed Nov 6, 2026

Cite this page

510(k) Report. “K915724: Model 6984M Lead Extender Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915724

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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