510(k) · Cleared
ClearedCardifix EZ Bipolar/Unipolar 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 Jun 19, 1996 as substantially equivalent to K922972 (Intermedics, Inc., 1993) and 2 other predicates after a 197-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Jun 19, 1996
- Review
- 197 days
- Class
- Class III
- Product code
- DTB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K902672 (1991). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK902672 Intermedics 430-07 Bipol Implant Endocard Pac LeadIntermedics, Inc. · 1991
- This deviceK955550 Cardifix EZ Bipolar/Unipolar Endocardial Pacing LeadIntermedics, 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 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −1 | K902672 | Intermedics 430-07 Bipol Implant Endocard Pac Lead | Intermedics, Inc. | 1991 | — |
| 0 (this device) | K955550 | Cardifix EZ Bipolar/Unipolar Endocardial Pacing Lead | Intermedics, Inc. | 1996 | — |
| +1 | 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 |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K922972 | Models 438-05 and 435-05 Implantable Pacing LeadSummary page 4…. The minimum introducer size recommended for the model 435-07 is 7.5 French. The models 438-07 and 435-07 pacing leads are identical to the Intermedics models 438-05 (K922972, K954719) and 435-05 (K922972, K954719) respectively, except for the use of iridium-oxide (IROX) coated titanium for the electrod… | 1993 |
| * | K954719 | Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing Lead Cleared while this submission was under review Summary page 4…nimum introducer size recommended for the model 435-07 is 7.5 French. The models 438-07 and 435-07 pacing leads are identical to the Intermedics models 438-05 (K922972, K954719) and 435-05 (K922972, K954719) respectively, except for the use of iridium-oxide (IROX) coated titanium for the electrodes. The I… | 1996 |
| * | K902672 | Intermedics 430-07 Bipol Implant Endocard Pac LeadSummary page 4…19) respectively, except for the use of iridium-oxide (IROX) coated titanium for the electrodes. The IROX-coated electrodes are identical to those used in models 430-07 (K902672, K954719) and 431-07 (K902672, K954719) except that the dimensions of the cathode tip have been slightly modified to accommodate… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962174 | Biplr IM EN Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07) | 1996 | 0 |
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?
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 438-07 and 435-07 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 (167 words)
The models 438-07 and 435-07 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.
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.
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/K955550 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955550: Cardifix EZ Bipolar/Unipolar 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/K955550
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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