510(k) · Cleared
ClearedBiplr IM EN Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)
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 Aug 21, 1996 as substantially equivalent to K890412 (Intermedics, Inc., 1989) and 7 other predicates after a 77-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Aug 21, 1996
- Review
- 77 days
- Class
- Class III
- Product code
- DTB
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 2 generations to K902672 (1991). 8 ancestors in all, the oldest K883602 (1988). No later device cites it as a predicate yet.
- Root · 2 generations backK902672 Intermedics 430-07 Bipol Implant Endocard Pac LeadIntermedics, Inc. · 1991
- 1 generation backK955550 Cardifix EZ Bipolar/Unipolar Endocardial Pacing LeadIntermedics, Inc. · 1996
- This deviceK962174 Biplr IM EN Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)Intermedics, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902672 | Intermedics 430-07 Bipol Implant Endocard Pac Lead | Intermedics, Inc. | 1991 | — |
| −1 | K955550 | Cardifix EZ Bipolar/Unipolar Endocardial Pacing Lead | Intermedics, Inc. | 1996 | — |
| 0 (this device) | K962174 | Biplr IM EN Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07) | Intermedics, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 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? (10)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K890412 | Models 430-07 & 431-07 Implantable Pacing LeadsSummary page 6…510(k) numbers and approval dates for each lead model. Table 2. 510(k) Numbers and approval dates for each lead model. | Lead Model 510(k) Number Approval Date 430-07 K890412 3/28/89 K902672 3/1/91 K954610 Submitted 10/03/95 . K954719 2/27/96 432-03 K890411 03/28/89 K912235 09/26/91 K954610 Submitted 10… | 1989 |
| * | K902672 | Intermedics 430-07 Bipol Implant Endocard Pac LeadSummary page 6…nd approval dates for each lead model. Table 2. 510(k) Numbers and approval dates for each lead model. | Lead Model 510(k) Number Approval Date 430-07 K890412 3/28/89 K902672 3/1/91 K954610 Submitted 10/03/95 . K954719 2/27/96 432-03 K890411 03/28/89 K912235 09/26/91 K954610 Submitted 10/03/95 K954719 2… | 1991 |
| Kept off the family tree | K954610 | FDA’s K954610 is Model 430-07 Endocardial Pacing Lead Our OCR of the scanned summary read K954610, which FDA decided on Dec 16, 1996, after this device was decided (Aug 21, 1996), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 6…es for each lead model. Table 2. 510(k) Numbers and approval dates for each lead model. | Lead Model 510(k) Number Approval Date 430-07 K890412 3/28/89 K902672 3/1/91 K954610 Submitted 10/03/95 . K954719 2/27/96 432-03 K890411 03/28/89 K912235 09/26/91 K954610 Submitted 10/03/95 K954719 2/27/96 436-02 K… | 1996 |
| * | K954719 | Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing LeadSummary page 6…le 2. 510(k) Numbers and approval dates for each lead model. | Lead Model 510(k) Number Approval Date 430-07 K890412 3/28/89 K902672 3/1/91 K954610 Submitted 10/03/95 . K954719 2/27/96 432-03 K890411 03/28/89 K912235 09/26/91 K954610 Submitted 10/03/95 K954719 2/27/96 436-02 K883602 09/06/88 K954719 02/27… | 1996 |
| * | K890411 | Models 432-03 & 433-03 Implantable Pacing LeadsSummary page 6…d approval dates for each lead model. | Lead Model 510(k) Number Approval Date 430-07 K890412 3/28/89 K902672 3/1/91 K954610 Submitted 10/03/95 . K954719 2/27/96 432-03 K890411 03/28/89 K912235 09/26/91 K954610 Submitted 10/03/95 K954719 2/27/96 436-02 K883602 09/06/88 K954719 02/27/96 436-07 K955122 Subm… | 1989 |
| * | K912235 | Models 432-03 & 433-03 Implant Endocard Pac LeadSummary page 6…for each lead model. | Lead Model 510(k) Number Approval Date 430-07 K890412 3/28/89 K902672 3/1/91 K954610 Submitted 10/03/95 . K954719 2/27/96 432-03 K890411 03/28/89 K912235 09/26/91 K954610 Submitted 10/03/95 K954719 2/27/96 436-02 K883602 09/06/88 K954719 02/27/96 436-07 K955122 Submitted 1 1/07/95 4… | 1991 |
| * | K883602 | Biopore VS.1 Endocardial Inter Implant Pacing LeadSummary page 6…07 K890412 3/28/89 K902672 3/1/91 K954610 Submitted 10/03/95 . K954719 2/27/96 432-03 K890411 03/28/89 K912235 09/26/91 K954610 Submitted 10/03/95 K954719 2/27/96 436-02 K883602 09/06/88 K954719 02/27/96 436-07 K955122 Submitted 1 1/07/95 438-05 K922972 01/22/93 K954719 02/27/96 438-07 K955550 Submitted 12… | 1988 |
| Kept off the family tree | K955122 | FDA’s K955122 is Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable… Our OCR of the scanned summary read K955122, which FDA decided on Nov 4, 1996, after this device was decided (Aug 21, 1996), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 6…Submitted 10/03/95 . K954719 2/27/96 432-03 K890411 03/28/89 K912235 09/26/91 K954610 Submitted 10/03/95 K954719 2/27/96 436-02 K883602 09/06/88 K954719 02/27/96 436-07 K955122 Submitted 1 1/07/95 438-05 K922972 01/22/93 K954719 02/27/96 438-07 K955550 Submitted 12/04/95 1. Labeling There are no changes… | 1996 |
| * | K922972 | Models 438-05 and 435-05 Implantable Pacing LeadSummary page 6…96 432-03 K890411 03/28/89 K912235 09/26/91 K954610 Submitted 10/03/95 K954719 2/27/96 436-02 K883602 09/06/88 K954719 02/27/96 436-07 K955122 Submitted 1 1/07/95 438-05 K922972 01/22/93 K954719 02/27/96 438-07 K955550 Submitted 12/04/95 1. Labeling There are no changes to the product labeling as a result… | 1993 |
| * | K955550 | Cardifix EZ Bipolar/Unipolar Endocardial Pacing Lead Cleared while this submission was under review Summary page 6…91 K954610 Submitted 10/03/95 K954719 2/27/96 436-02 K883602 09/06/88 K954719 02/27/96 436-07 K955122 Submitted 1 1/07/95 438-05 K922972 01/22/93 K954719 02/27/96 438-07 K955550 Submitted 12/04/95 1. Labeling There are no changes to the product labeling as a result of the modification to the manufacturin… | 1996 |
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?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 5.3 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K890412.
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?
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, 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…
Read the full statement (158 words)
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, 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.
Active fixation leads are specifically indicated for use in cases where passive-fixation leads provide unsatisfactory positional stability in either the atrium or the ventricle, or in cases where the atrial appendage has been sacrificed due to open-heart surgery or is abnormal because of congenital or acquired heart disease.
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/K962174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962174: Biplr IM EN Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962174
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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