510(k) · Cleared
ClearedIntermedics Model 430-07 Bipolar Implantable Endocardial Pacing Lead
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intermedics, Inc. · DTB Permanent Pacemaker Electrode
Cleared on Feb 27, 1996 after a 137-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 27, 1996
- Review
- 137 days
- Class
- Class III
- Product code
- DTB
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK954719 Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing LeadIntermedics, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK955550 Cardifix EZ Bipolar/Unipolar Endocardial Pacing LeadIntermedics, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK955122 Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable…Intermedics, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK962174 Biplr IM EN Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)Intermedics, Inc. · 1996
Most influential descendants
Showing 3 of 3 · See all- K955550Cardifix EZ Bipolar/Unipolar Endocardial Pacing LeadIntermedics, Inc. · 1996 · cites it directly1descendant
- K955122Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable Endocardial Pacing…Intermedics, Inc. · 1996 · cites it directly0descendants
- K962174Biplr IM EN Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)Intermedics, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954719 | Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing Lead | Intermedics, Inc. | 1996 | — |
| +1 | K955550 | Cardifix EZ Bipolar/Unipolar Endocardial Pacing Lead | Intermedics, Inc. | 1996 | — |
| +1 | K955122 | Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable… | Intermedics, Inc. | 1996 | — |
| +1 | K962174 | Biplr IM EN Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07) | Intermedics, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 3 | 0 |
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 DTB? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K955550 (Intermedics, Inc., 1996) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DTB devicesDTB Permanent Pacemaker Electrode: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTB
Too few DTB 510(k)s in any year since 2007 to give a median.
Recalls per year · DTB
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTB
25,591in 2025
MAUDE reports naming product code DTB, 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 | 5,401 |
| 2008 | 0 | — | 1 | 6,469 |
| 2009 | 0 | — | 2 | 7,565 |
| 2010 | 0 | — | 2 | 14,285 |
| 2011 | 0 | — | 0 | 12,555 |
| 2012 | 0 | — | 0 | 12,230 |
| 2013 | 0 | — | 0 | 10,102 |
| 2014 | 0 | — | 0 | 13,324 |
| 2015 | 3 | — | 1 | 11,071 |
| 2016 | 8 | — | 0 | 11,839 |
| 2017 | 5 | — | 0 | 11,495 |
| 2018 | 6 | — | 0 | 15,209 |
| 2019 | 7 | — | 0 | 16,812 |
| 2020 | 6 | — | 0 | 17,859 |
| 2021 | 3 | — | 0 | 18,442 |
| 2022 | 4 | — | 0 | 19,444 |
| 2023 | 7 | — | 0 | 34,542 |
| 2024 | 3 | — | 0 | 25,689 |
| 2025 | 1 | — | 0 | 25,591 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K954719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954719: Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing Lead.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954719
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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