510(k) Report

510(k) · Cleared

Cleared

EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133

K994240510(k) TraditionalCleared Apr 13, 2000119-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, Inc. · DTB Permanent Pacemaker Electrode

Cleared on Apr 13, 2000 as substantially equivalent to K981083 (Biotronik, Inc., 1998) and 3 other predicates after a 119-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.

Decided
Apr 13, 2000
Review
119 days
Class
Class III
Product code
DTB
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K843707 (1985). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 2 other ancestors1991: 1 other ancestor2003: 1 descendant clearedK843707 · Medtronic 6957J · Medtronic Vascular · 19851990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant K843707 · Medtronic 6957J · Medtronic Vascular · 19850
  1. Root · 1 generation backK843707 Medtronic 6957JMedtronic Vascular · 1985
  2. This deviceK994240 EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model…Biotronik, Inc. · 2000
  3. Descendant · cites it directly · 0 of its ownK023205 Elox P 45-BP; Elox P 53-BP; Elox P 60-BPBiotronik, Inc. · 2003

Most influential descendants

Showing 1 of 1 · See all
  • K023205Elox P 45-BP; Elox P 53-BP; Elox P 60-BPBiotronik, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K843707Medtronic 6957JMedtronic Vascular1985—
0 (this device)K994240EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133Biotronik, Inc.2000—
+1K023205Elox P 45-BP; Elox P 53-BP; Elox P 60-BPBiotronik, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K994240, 1985–2003Source: 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), 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
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What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K981083Retrox RX 53-BP, Retrox RX 60-BP, Retrox RX 45-JBP, Retrox RX 53-JBP Model Numbers 124…
Summary page 1
…poses the foliowing leads cleared through 510(k) notifications as predicate devices for the Elox lead: + BIOTRONIK's Retrox bipolar, active fixation, endocardial lead (#K981083, cleared 07/22/98) + Medtronic’s Model 6957J-58 unipolar, active fixation, endocardial lead (#K843707, cleared 01/08/85) o BIOT…
Biotronik, Inc.1998—
*K843707Medtronic 6957J
Summary page 1
…+ BIOTRONIK's Retrox bipolar, active fixation, endocardial lead (#K981083, cleared 07/22/98) + Medtronic’s Model 6957J-58 unipolar, active fixation, endocardial lead (#K843707, cleared 01/08/85) o BIOTRONIK's FH bipolar, active fixation, endocardial lead (#K910608, cleared 07/30/91) » BIOTRONIK’s Synox…
Medtronic Vascular1985—
*K910608Permanent Implantable FH Endocardial Leads W/Tip
Summary page 1
…98) + Medtronic’s Model 6957J-58 unipolar, active fixation, endocardial lead (#K843707, cleared 01/08/85) o BIOTRONIK's FH bipolar, active fixation, endocardial lead (#K910608, cleared 07/30/91) » BIOTRONIK’s Synox bipolar, passive fixation, endocardial lead (#K980869, cleared 09/10/98) Indications for…
Biotronik, GmbH & Co.1991—
*K980869Synox SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , Models 120 444, 119 684, 120 438 and…
Summary page 1
…ed 01/08/85) o BIOTRONIK's FH bipolar, active fixation, endocardial lead (#K910608, cleared 07/30/91) » BIOTRONIK’s Synox bipolar, passive fixation, endocardial lead (#K980869, cleared 09/10/98) Indications for Use: BIOTRONIK’'s ELOX (EX xx-BP) transvenous, active fixation endocardial leads are indicat…
Biotronik, Inc.1998—

Also cleared against K981083: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K023205Elox P 45-BP; Elox P 53-BP; Elox P 60-BPBiotronik, Inc.20030

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 4 ancestors has a recall.
  • Of its descendants, K023205 (Biotronik, Inc., 2003) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K981083.

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—

What is it indicated for?

BIOTRONIK’s ELOX (EX xx-BP) transvenous, active fixation endocardial leads are indicated for

permanent pacing and sensing. Active fixation pacing leads with a bipolar (BP) IS-1 connector

configuration are designed for use in conjunction with implantable pulse generators with IS-1 headers.

The leads may be used with single or dual chamber pacing systems.

The ELOX (EX xx-BP) lead models are intended for placement in either the right atrium or right ventricle.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K981083

1 other device cites the same predicate.

  • K990483Retrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777Biotronik, Inc. · 1999

More from Biotronik, Inc.

1,088 FDA decisions under this applicant name. See the company

  • P980023/S153Ilivia Neo 7 VRT DX, Intica Neo 7 VRT DX, Intica Neo 5 VRT DX, Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor…Biotronik, Inc. · 2026
  • P950037/S299Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6…Biotronik, Inc. · 2026
  • P050023/S216Ilivia 7 VRT DX, Intica 7 VRT DX, Intica 5 VRT DX, Ilivia 7 VRT, Intica 7 VRT, Intica 5 VRT, Inlexa 7 VRT…Biotronik, Inc. · 2026
  • P000009/S135Ilivia Neo 7 DRT, Intica Neo 7 DRT, Intica Neo 5 DRT, Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T…Biotronik, Inc. · 2026
  • P070008/S184Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75…Biotronik, Inc. · 2026

Recent decisions in DTB

The DTB category page

https://510kreport.com/device/K994240 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994240: EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994240

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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