510(k) · Cleared
ClearedIntermedics Model 436-07 Bipolar & Model 437-07 Unipolar 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 Nov 4, 1996 as substantially equivalent to K883602 (Intermedics, Inc., 1988) and 2 other predicates after a 361-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Nov 4, 1996
- Review
- 361 days
- Class
- Class III
- Product code
- DTB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K883602 (1988). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK883602 Biopore VS.1 Endocardial Inter Implant Pacing LeadIntermedics, Inc. · 1988
- This deviceK955122 Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable…Intermedics, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883602 | Biopore VS.1 Endocardial Inter Implant Pacing Lead | Intermedics, Inc. | 1988 | — |
| 0 (this device) | K955122 | Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable… | Intermedics, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 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 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? (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 |
|---|---|---|---|
| * | K883602 | Biopore VS.1 Endocardial Inter Implant Pacing LeadSummary page 3…). The minimum introducer size recommended for both lead models is 10 French. The models 436-07 and 437-07 pacing leads are identical to the Intermedics models 436-02 (K883602, K954719) and 437-02 (K883602, K954719) respectively, except for the use of iridium-oxide (IROX) coated titanium for the === Pag… | 1988 |
| * | K954719 | Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing Lead Cleared while this submission was under review Summary page 3…inimum introducer size recommended for both lead models is 10 French. The models 436-07 and 437-07 pacing leads are identical to the Intermedics models 436-02 (K883602, K954719) and 437-02 (K883602, K954719) respectively, except for the use of iridium-oxide (IROX) coated titanium for the 0… | 1996 |
| * | K902672 | Intermedics 430-07 Bipol Implant Endocard Pac LeadSummary page 4…S10(K) SUMMARY, SUMMARY OF ADVERSE SAFETY AND EFFECTIVENESS DATA AND CERTIFICATION electrodes. The IROX-coated electrodes are identical to those used in models 430-07 (K902672, K954719) and 431-07 (K902672, K954719). 1. Labeling The generic Intermedics Endocardial Pacing Leads Package insert accompani… | 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.
- 2 other devices also cite its predicate K883602.
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 | — |
What is it indicated for?
The models 436-07 and 437-07 pacing leads are intended for use with implantable cardiac pulse generators for long-term pacing of the heart. The indications for ventricular pacing include, but are not limited to: Sick sinus syndrome, sinus bradycardia, complete heart block, symptomatic second-degree heart block, and certain conditions of asymptomatic second-degree block. In the presence of normal A-V conduction the indications for atrial pacing include…
Read the full statement (120 words)
The models 436-07 and 437-07 pacing leads are intended for use with implantable cardiac pulse generators for long-term pacing of the heart. The indications for ventricular pacing include, but are not limited to: Sick sinus syndrome, sinus bradycardia, complete heart block, symptomatic second-degree heart block, and certain conditions of asymptomatic second-degree block.
In the presence of normal A-V conduction the indications for atrial pacing include, but are not limited to: Sinus arrest, sick sinus syndrome, sinus bradycardia and conditions requiring increased cardiac efficiency, enhanced cardiac output or the overdrive of certain cardiac arrhythmias.
In the absence of normal A-V conduction, an atrial lead may be used with a ventricular lead in a dual chamber pacing system to restore A-V synchrony.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K955122 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955122: Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable Endocardial Pacing Lead.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955122
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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