510(k) · Cleared
Cleared6981M Lead Extender Kit, 6984M Lead Extender Kit, 6986M Lead Extender Kit, 5866-24M Lead Adaptor Kit, 5866-38M Lead Adap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DTD Pacemaker Lead Adaptor
Cleared on Jul 30, 2013 as substantially equivalent to K911827 (Metronic, Inc., 1991) and 2 other predicates after a 29-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Jul 30, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- DTD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K911827 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK911827 Model 5866-9M & Model 6981MMetronic, Inc. · 1991
- This deviceK132008 6981M Lead Extender Kit, 6984M Lead Extender Kit, 6986M Lead…Medtronic, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911827 | Model 5866-9M & Model 6981M | Metronic, Inc. | 1991 | — |
| 0 (this device) | K132008 | 6981M Lead Extender Kit, 6984M Lead Extender Kit, 6986M Lead Extender Kit… | Medtronic, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K911827 | Model 5866-9M & Model 6981MSummary page 2…lications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510 (k) Submissions" Predicate Devices K91 1827 698 1M Lead Extender Kit K9 15724 6984M Lead Extender Kit K91 1302… | 1991 |
| * | K915724 | Model 6984M Lead Extender KitSummary page 2…acemaker Leads and for Pacemaker Lead Adaptor 510 (k) Submissions" Predicate Devices K91 1827 698 1M Lead Extender Kit K9 15724 6984M Lead Extender Kit K91 1302 5866-24M Lead Adaptor Kit… | 1992 |
| * | K911302 | Models 5866-24M/5866-38M/5866-40M/6986M Adapt KitSummary page 2…Submissions" Predicate Devices K91 1827 698 1M Lead Extender Kit K9 15724 6984M Lead Extender Kit K91 1302 5866-24M Lead Adaptor Kit 5866-38M Lead Adaptor Kit… | 1991 |
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.
What does this lineage say?
- None of the 3 ancestors has a recall.
How does its category compare?
All DTD devicesDTD Pacemaker Lead Adaptor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DTD
1in 2015
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
MAUDE reports naming product code DTD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 8 |
| 2008 | 0 | — | 0 | 8 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 36 |
| 2011 | 0 | — | 0 | 18 |
| 2012 | 0 | — | 0 | 19 |
| 2013 | 1 | — | 0 | 30 |
| 2014 | 0 | — | 0 | 21 |
| 2015 | 1 | — | 0 | 41 |
| 2016 | 0 | — | 0 | 20 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 0 | — | 0 | 29 |
| 2019 | 0 | — | 0 | 34 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 0 | — | 0 | 25 |
| 2023 | 0 | — | 0 | 28 |
| 2024 | 0 | — | 0 | 35 |
| 2025 | 0 | — | 0 | 32 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The 698I1M Lead extender kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a unipolar connector that meets the (I S-I UNI) standard. The 6984M Lead Extender Kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a bipolar connector that meets the (IS- I BI1) standard. The 5866-24M Lead adaptor kit is designed to connect a Medtronic pacing lead with a bipolar connector (5mm bifurcated)…
Read the full statement (219 words)
The 698I1M Lead extender kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a unipolar connector that meets the (I S-I UNI) standard.
The 6984M Lead Extender Kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a bipolar connector that meets the (IS- I BI1) standard.
The 5866-24M Lead adaptor kit is designed to connect a Medtronic pacing lead with a bipolar connector (5mm bifurcated) to a pulse generator featuring a bipolar connector block which meets the (IS-I BI) standard.
The 5866-38M Lead adaptor kit is designed to connect two pacing leads with unipolar connectors (IS- I UN!) to a pulse generator featuring a bipolar connector block which meets the (IS-I BI) standard.
The Model 5866-40M Lead Adaptor Kit is designed to connect a Medtronic pacing lead with a bipolar connector (3.2 mm low-profile) to a pulse generator featuring a bipolar connector block which meets the (IS-I BI) standard and has a short-pin cavity and no sealing rings.
The 6986M Lead adaptor/Extender kit is designed to extend, by 37 cm (14.6 in.), the length of a 3.2 mm low-profile connector pacing lead system and connect to a pulse generator featuring a bipolar connector block that meets the (IS- I B1) standard.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132008 · printed Nov 3, 2026
Cite this page
510(k) Report. “K132008: 6981M Lead Extender Kit, 6984M Lead Extender Kit, 6986M Lead Extender Kit, 5866-24M Lead Adaptor Kit, 5866-38M Lead Adap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K132008
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026