510(k) · Cleared
ClearedImplantable Pacing Leads/Implantable Accessory/Non-Implantable Accessory
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 18, 1996 as substantially equivalent to K883602 (Intermedics, Inc., 1988) and 9 other predicates after a 151-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Jun 18, 1996
- Review
- 151 days
- Class
- Class III
- Product code
- DTB
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 1 generation to K862276 (1986). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK862276 Model 435-02 Cardifix Implantable Pacing LeadIntermedics, Inc. · 1986
- This deviceK960281 Implantable Pacing Leads/Implantable Accessory/Non-Implantable…Intermedics, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862276 | Model 435-02 Cardifix Implantable Pacing Lead | Intermedics, Inc. | 1986 | — |
| 0 (this device) | K960281 | Implantable Pacing Leads/Implantable Accessory/Non-Implantable Accessory | Intermedics, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 3 | 0 |
| 1989 | 2 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K883602 | Biopore VS.1 Endocardial Inter Implant Pacing LeadSummary page 8…S10(X) SUMMARY and approval dates for each lead model. Table 2. 510(k) Numbers and approval dates for each lead model. L Lead Model 510(k) Number Approval Date 431-04 K883602 09/06/88 431-07 K890412 03/28/89 K902672 03/01/91 K954610 Submitted 10/03/95 K954719 Submitted 10/12/95 433-02 K 883602 09/06/88… | 1988 |
| * | K890412 | Models 430-07 & 431-07 Implantable Pacing LeadsSummary page 8…oval dates for each lead model. Table 2. 510(k) Numbers and approval dates for each lead model. L Lead Model 510(k) Number Approval Date 431-04 K883602 09/06/88 431-07 K890412 03/28/89 K902672 03/01/91 K954610 Submitted 10/03/95 K954719 Submitted 10/12/95 433-02 K 883602 09/06/88 433-03 K890411 03/28/89… | 1989 |
| * | K902672 | Intermedics 430-07 Bipol Implant Endocard Pac LeadSummary page 8…h lead model. Table 2. 510(k) Numbers and approval dates for each lead model. L Lead Model 510(k) Number Approval Date 431-04 K883602 09/06/88 431-07 K890412 03/28/89 K902672 03/01/91 K954610 Submitted 10/03/95 K954719 Submitted 10/12/95 433-02 K 883602 09/06/88 433-03 K890411 03/28/89 K912235 09/26/91… | 1991 |
| * | K890411 | Models 432-03 & 433-03 Implantable Pacing LeadsSummary page 8…ber Approval Date 431-04 K883602 09/06/88 431-07 K890412 03/28/89 K902672 03/01/91 K954610 Submitted 10/03/95 K954719 Submitted 10/12/95 433-02 K 883602 09/06/88 433-03 K890411 03/28/89 K912235 09/26/91 K954610 Submitted 10/03/95 K954719 Submitted 10/12/95 435-02 K862276 07/02/86 K954719 Submitted 10/12/9… | 1989 |
| * | K912235 | Models 432-03 & 433-03 Implant Endocard Pac LeadSummary page 8…431-04 K883602 09/06/88 431-07 K890412 03/28/89 K902672 03/01/91 K954610 Submitted 10/03/95 K954719 Submitted 10/12/95 433-02 K 883602 09/06/88 433-03 K890411 03/28/89 K912235 09/26/91 K954610 Submitted 10/03/95 K954719 Submitted 10/12/95 435-02 K862276 07/02/86 K954719 Submitted 10/12/95 435-05 K922972… | 1991 |
| * | K862276 | Model 435-02 Cardifix Implantable Pacing LeadSummary page 8…mitted 10/03/95 K954719 Submitted 10/12/95 433-02 K 883602 09/06/88 433-03 K890411 03/28/89 K912235 09/26/91 K954610 Submitted 10/03/95 K954719 Submitted 10/12/95 435-02 K862276 07/02/86 K954719 Submitted 10/12/95 435-05 K922972 01/22/93 K954719 Submitted 10/12/95 435-07 K955550 Submitted 12/04/95 435-08 K… | 1986 |
| * | K922972 | Models 438-05 and 435-05 Implantable Pacing LeadSummary page 8…883602 09/06/88 433-03 K890411 03/28/89 K912235 09/26/91 K954610 Submitted 10/03/95 K954719 Submitted 10/12/95 435-02 K862276 07/02/86 K954719 Submitted 10/12/95 435-05 K922972 01/22/93 K954719 Submitted 10/12/95 435-07 K955550 Submitted 12/04/95 435-08 K922042 04/29/93 437-02 K 883602 09/06/88 K954719 Su… | 1993 |
| * | K922042 | Cardifix Endocardial Pacing LeadSummary page 8…K954719 Submitted 10/12/95 435-02 K862276 07/02/86 K954719 Submitted 10/12/95 435-05 K922972 01/22/93 K954719 Submitted 10/12/95 435-07 K955550 Submitted 12/04/95 435-08 K922042 04/29/93 437-02 K 883602 09/06/88 K954719 Submitted 10/12/95 510(K) NOTIFICATION - CFC-FREE MANUFACTURING PROCESS… | 1993 |
| * | K874531 | Polyflex (R) Epicardial 439-04 Implant Pacing LeadSummary page 9…PROCESS 510(X) SUMMARY Table 2. 510(k) Numbers and approval dates for each lead model. Lead Model 510(k) Number Approval Date 437-07 K955122 Submitted 11/07/95 439-04 K874531 01/07/88 "K954719 Submitted 10/12/95 439-07 K880551 03/07/88 | K954719 Submitted 10/12/95 1. Labeling hgl There are no changes… | 1988 |
| * | K880551 | Model 439-07 and 439-09 Lifeline Myocardial LeadSummary page 9…approval dates for each lead model. Lead Model 510(k) Number Approval Date 437-07 K955122 Submitted 11/07/95 439-04 K874531 01/07/88 "K954719 Submitted 10/12/95 439-07 K880551 03/07/88 | K954719 Submitted 10/12/95 1. Labeling hgl There are no changes to the product labeling as a result of the modificat… | 1988 |
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 10 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 indications for use of Intermedics Models 431-04, 431-07, 433-02, 433-03, 435-02, 435-05, 435-07, 435-08, 437-02, and 437-07 endocardial pacing leads, model 439-04 epicardial pacing lead, model 439-07 myocardial pacing lead, implantable accessory models 365-07, 365-09, 365-14, 365-17, 365-19, 365-22, 365-33, 365-34, 36544, 365-49, 366-13, 366-15, 366-27, 366-28, 366-29, and 366-30, and non-implantable accessory models 365-62, 365-77, 365-29, 366-02…
Read the full statement (332 words)
The indications for use of Intermedics Models 431-04, 431-07, 433-02, 433-03, 435-02, 435-05, 435-07, 435-08, 437-02, and 437-07 endocardial pacing leads, model 439-04 epicardial pacing lead, model 439-07 myocardial pacing lead, implantable accessory models 365-07, 365-09, 365-14, 365-17, 365-19, 365-22, 365-33, 365-34, 36544, 365-49, 366-13, 366-15, 366-27, 366-28, 366-29, and 366-30, and non-implantable accessory models 365-62, 365-77, 365-29, 366-02, 366-17, and 367:01, manufactured using a Chlorofluorocarbon (CFC) Free process, are identical to those for the commercially available leads and accessories with the same model numbers manufactured using Freon-TMS.
Pacing leads and accessories are intended for use with implantable cardiac palse 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.
Suture-on epicardial leads (model 439-04) and screw-on (sutureless) myocardial leads (model 439-07), placed on the outside of the heart, are indicated for use when cardiac pacing is indicated and a suture-on lead is preferred, or when an endocardial lead cannot achieve satisfactory results. Such leads are particularly well suited to patients whose age or heart condition requires that the potential for lead dislodgment be minimized (i.e. patients who have not reached full physical maturity) and patients who may require cardiac pacing following open-chest surgery.
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/K960281 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960281: Implantable Pacing Leads/Implantable Accessory/Non-Implantable Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960281
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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