510(k) Report

510(k) · Cleared

Cleared

Elox P 45-BP; Elox P 53-BP; Elox P 60-BP

K023205510(k) TraditionalCleared Apr 24, 2003211-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 24, 2003 as substantially equivalent to K994240 (Biotronik, Inc., 2000) and 3 other predicates after a 211-day review. Its family tree reaches back 2 generations to 1985.

Decided
Apr 24, 2003
Review
211 days
Class
Class III
Product code
DTB
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K843707 (1985). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestor1998: 2 other ancestors1991: 2 other ancestorsK843707 · Medtronic 6957J · Medtronic Vascular · 1985K994240 · EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133 · Biotronik, Inc. · 200019851990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors K994240 · EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133 · Biotronik, Inc. · 2000K843707 · Medtronic 6957J · Medtronic Vascular · 19850
  1. Root · 2 generations backK843707 Medtronic 6957JMedtronic Vascular · 1985
  2. 1 generation backK994240 EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model…Biotronik, Inc. · 2000
  3. This deviceK023205 Elox P 45-BP; Elox P 53-BP; Elox P 60-BPBiotronik, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K843707Medtronic 6957JMedtronic Vascular1985—
−1K994240EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133Biotronik, Inc.2000—
0 (this device)K023205Elox P 45-BP; Elox P 53-BP; Elox P 60-BPBiotronik, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199120
199820
200010
FIG. 1 — Lineage of K023205, 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
*K994240EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133
Summary page 1
…53 cm. and 60 cm. Device Modification: The proposed Elox P leads in this Special 510(k] notification are modified versions of BIOTRONIK'S currently marketed Elox leads (K994240. cleared 04-13-00 and KO01413. cleared 06-02-001. The modification to the Elox P lead involves the addition of a Parylene C coati…
Biotronik, Inc.2000—
*K001413Elox 45-BP, Model 330 132, Efh-27, Model 331 549, Extension Tool, Model 331 668
Our reading of the summary gave K001416, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “BIOTRONIK's Elox 45-BP bipolar, active fixation, endocardial leads”.
Biotronik, Inc.2000—
*K980869Synox SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , Models 120 444, 119 684, 120 438 and…
Summary page 1
…ox 45-BP bipolar, active fixation, endocardial leads [#KO0141 6, cleared 06-02-001 BIOTRONIK'S Synox bipolar, passive fixation endocardial leads with 31 mm spacing (#K980869. cleared 09-10-981 Intermedics's Quantum implantable pulse generator (#K911122. cleared 05-16-91 1 Indications for Use: B…
Biotronik, Inc.1998—
*K9111228MM Quantum Pulse/Suprima II Pulse Generators
Summary page 1
…BIOTRONIK'S Synox bipolar, passive fixation endocardial leads with 31 mm spacing (#K980869. cleared 09-10-981 Intermedics's Quantum implantable pulse generator (#K911122. cleared 05-16-91 1 Indications for Use: BIOTRONIK's ELOX P transvenous. active fixation endocardial leads are indicated for perm…
Intermedics, Inc.1991—

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?

  • The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 15.3 years on median.
  • None of the 7 ancestors has a recall.

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 P 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 P lead models are intended for placement in either the right atrium or right ventricle

Indications for use as stated in the FDA summary.

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/K023205 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023205: Elox P 45-BP; Elox P 53-BP; Elox P 60-BP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023205

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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