510(k) Report

510(k) · Cleared

Cleared

Permanent Implantable FH Endocardial Leads W/Tip

K910608510(k) TraditionalCleared Jul 30, 1991168-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

Biotronik, GmbH & Co. · DTB Permanent Pacemaker Electrode

Cleared on Jul 30, 1991 after a 168-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
Jul 30, 1991
Review
168 days
Class
Class III
Product code
DTB
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared1999: 1 descendant cleared2003: 1 descendant cleared1990200020102020
  1. This deviceK910608 Permanent Implantable FH Endocardial Leads W/TipBiotronik, GmbH & Co. · 1991
  2. Descendant · cites it directly · 1 of its ownK994240 EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model…Biotronik, Inc. · 2000
  3. Descendant · 2 generations on · 0 of its ownK023205 Elox P 45-BP; Elox P 53-BP; Elox P 60-BPBiotronik, Inc. · 2003
  4. Descendant · cites it directly · 0 of its ownK993139 YP 45/15-BP; YP 53/15-BP; YP 60/15-BPBiotronik, Inc. · 1999

Most influential descendants

Showing 3 of 3 · See all
  • K994240EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133Biotronik, Inc. · 2000 · cites it directly1descendant
  • K023205Elox P 45-BP; Elox P 53-BP; Elox P 60-BPBiotronik, Inc. · 2003 · 2 generations on0descendants
  • K993139YP 45/15-BP; YP 53/15-BP; YP 60/15-BPBiotronik, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K910608Permanent Implantable FH Endocardial Leads W/TipBiotronik, GmbH & Co.1991—
+1K994240EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133Biotronik, Inc.2000—
+2K023205Elox P 45-BP; Elox P 53-BP; Elox P 60-BPBiotronik, Inc.2003—
+1K993139YP 45/15-BP; YP 53/15-BP; YP 60/15-BPBiotronik, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200310
FIG. 1 — Lineage of K910608, 1991–2003Source: 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.

  • Candidate predicates for a device like this, rankedin the report
  • 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)

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

NumberDeviceApplicantDecidedDescendants
K994240EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133Biotronik, Inc.20001
K993139YP 45/15-BP; YP 53/15-BP; YP 60/15-BPBiotronik, Inc.19990

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, K994240 (Biotronik, Inc., 2000) 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 Biotronik, GmbH & Co.

18 FDA decisions under this applicant name. See the company

  • K000763PX 53/15-BP, Model 130 050 and PX 60/15-BP, Model 130 051Biotronik, GmbH & Co. · 2000
  • K923406BioscopeBiotronik, GmbH & Co. · 1993
  • K923026Pikos 01-a and Pikos E01-a Implantable PacemakerBiotronik, GmbH & Co. · 1993
  • K922742HPM 40 Heart Pacemaker MonitorBiotronik, GmbH & Co. · 1993
  • K914109Pikos 01 & Pikos E 01Biotronik, GmbH & Co. · 1992

Recent decisions in DTB

The DTB category page

https://510kreport.com/device/K910608 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910608: Permanent Implantable FH Endocardial Leads W/Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910608

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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