510(k) Report

510(k) · Cleared

Cleared

Polyflex (R) Epicardial 439-04 Implant Pacing Lead

K874531510(k) TraditionalCleared Jan 7, 198865-day reviewClass III21 CFR 870.3680

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Intermedics, Inc. · DTB Permanent Pacemaker Electrode

Cleared on Jan 7, 1988 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jan 7, 1988
Review
65 days
Class
Class III
Product code
DTB
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1990200020102020
  1. This deviceK874531 Polyflex (R) Epicardial 439-04 Implant Pacing LeadIntermedics, Inc. · 1988
  2. Descendant · cites it directly · 0 of its ownK960281 Implantable Pacing Leads/Implantable Accessory/Non-Implantable…Intermedics, Inc. · 1996

Most influential descendants

Showing 1 of 1 · See all
  • K960281Implantable Pacing Leads/Implantable Accessory/Non-Implantable AccessoryIntermedics, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K874531Polyflex (R) Epicardial 439-04 Implant Pacing LeadIntermedics, Inc.1988—
+1K960281Implantable Pacing Leads/Implantable Accessory/Non-Implantable AccessoryIntermedics, Inc.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K874531, 1988–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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  • Recall history across each candidate’s familyin the report
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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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K960281Implantable Pacing Leads/Implantable Accessory/Non-Implantable AccessoryIntermedics, Inc.19960

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, K960281 (Intermedics, Inc., 1996) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DTB devices

DTB Permanent Pacemaker Electrode: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTB

1in 2025

2015: 32016: 82017: 52018: 62019: 72020: 62021: 32022: 42023: 72024: 32025: 12026 (partial year): 2
2007high 8 (2016) · low 0 (2007)2026

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

2008: 12009: 22010: 22015: 1
2007high 2 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DTB

25,591in 2025

2007: 5,4012008: 6,4692009: 7,5652010: 14,2852011: 12,5552012: 12,2302013: 10,1022014: 13,3242015: 11,0712016: 11,8392017: 11,4952018: 15,2092019: 16,8122020: 17,8592021: 18,4422022: 19,4442023: 34,5422024: 25,6892025: 25,591
2007high 34,542 (2023) · low 5,401 (2007)2025

MAUDE reports naming product code DTB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—05,401
20080—16,469
20090—27,565
20100—214,285
20110—012,555
20120—012,230
20130—010,102
20140—013,324
20153—111,071
20168—011,839
20175—011,495
20186—015,209
20197—016,812
20206—017,859
20213—018,442
20224—019,444
20237—034,542
20243—025,689
20251—025,591
20262—0—

More from Intermedics, Inc.

211 FDA decisions under this applicant name. See the company

  • K954610Model 430-07 Endocardial Pacing LeadIntermedics, Inc. · 1996
  • K955122Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable Endocardial Pacing LeadIntermedics, Inc. · 1996
  • K962174Biplr IM EN Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)Intermedics, Inc. · 1996
  • K955550Cardifix EZ Bipolar/Unipolar Endocardial Pacing LeadIntermedics, Inc. · 1996
  • K960281Implantable Pacing Leads/Implantable Accessory/Non-Implantable AccessoryIntermedics, Inc. · 1996

Recent decisions in DTB

The DTB category page

https://510kreport.com/device/K874531 · printed Nov 4, 2026

Cite this page

510(k) Report. “K874531: Polyflex (R) Epicardial 439-04 Implant 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/K874531

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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