510(k) Report

510(k) · Decided

Decided

Models 438-05 and 435-05 Implantable Pacing Lead

K922972510(k) TraditionalDecided Jan 22, 1993217-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 22, 1993 after a 217-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jan 22, 1993
Review
217 days
Class
Class III
Product code
DTB
Recalls
None
Predicates
0

3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1996: 3 descendants cleared1990200020102020
  1. This deviceK922972 Models 438-05 and 435-05 Implantable Pacing LeadIntermedics, Inc. · 1993
  2. Descendant · cites it directly · 1 of its ownK955550 Cardifix EZ Bipolar/Unipolar Endocardial Pacing LeadIntermedics, Inc. · 1996
  3. 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
  4. Descendant · cites it directly · 0 of its ownK960281 Implantable Pacing Leads/Implantable Accessory/Non-Implantable…Intermedics, Inc. · 1996

Most influential descendants

Showing 3 of 3 · See all
  • K955550Cardifix EZ Bipolar/Unipolar Endocardial Pacing LeadIntermedics, Inc. · 1996 · cites it directly1descendant
  • K962174Biplr IM EN Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)Intermedics, Inc. · 1996 · cites it directly0descendants
  • 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)K922972Models 438-05 and 435-05 Implantable Pacing LeadIntermedics, Inc.1993—
+1K955550Cardifix EZ Bipolar/Unipolar Endocardial Pacing LeadIntermedics, Inc.1996—
+1K962174Biplr IM EN Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)Intermedics, Inc.1996—
+1K960281Implantable Pacing Leads/Implantable Accessory/Non-Implantable AccessoryIntermedics, Inc.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199630
FIG. 1 — Lineage of K922972, 1993–1996Source: 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.

Planning a device in DTB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K955550Cardifix EZ Bipolar/Unipolar Endocardial Pacing LeadIntermedics, Inc.19961
K962174Biplr IM EN Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)Intermedics, Inc.19960
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, K955550 (Intermedics, Inc., 1996) has gone furthest, with 1 descendant 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/K922972 · printed Nov 5, 2026

Cite this page

510(k) Report. “K922972: Models 438-05 and 435-05 Implantable Pacing Lead.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K922972

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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