510(k) Report

510(k) · Cleared

Cleared

YP 45/15-BP; YP 53/15-BP; YP 60/15-BP

K993139510(k) TraditionalCleared Dec 17, 199988-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 Dec 17, 1999 as substantially equivalent to K990483 (Biotronik, Inc., 1999) and 2 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1993.

Decided
Dec 17, 1999
Review
88 days
Class
Class III
Product code
DTB
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K920662 (1993). 5 ancestors in all, the oldest K841451 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1991: 1 other ancestor1985: 1 other ancestor1998: 1 other ancestorK920662 · Vascotwist 9/60 · Vascor Medical Corp. · 1993K990483 · Retrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 · Biotronik, Inc. · 19991985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor K990483 · Retrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 · Biotronik, Inc. · 1999K920662 · Vascotwist 9/60 · Vascor Medical Corp. · 19930
  1. Root · 2 generations backK920662 Vascotwist 9/60Vascor Medical Corp. · 1993
  2. 1 generation backK990483 Retrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777Biotronik, Inc. · 1999
  3. This deviceK993139 YP 45/15-BP; YP 53/15-BP; YP 60/15-BPBiotronik, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K920662Vascotwist 9/60Vascor Medical Corp.1993—
−1K990483Retrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777Biotronik, Inc.1999—
0 (this device)K993139YP 45/15-BP; YP 53/15-BP; YP 60/15-BPBiotronik, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199110
199810
FIG. 1 — Lineage of K993139, 1993–1999Source: 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K990483Retrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777
Summary page 1
…h BIOTRONIK is basing its claim of substantial equivalence are the following: » BIOTRONIK's Retrox family of bipolar, active fixation, endocardial leads with Elgiloy® (#K990483, cleared 06/03/99). » BIOTRONIK's DY unipolar, active fixation, endocardial lead (#K841451/A, cleared 02/07/85). e BIOTRONIK's…
Biotronik, Inc.1999—
*K841451Biotronik DY-Unipolar
Summary page 1
…Retrox family of bipolar, active fixation, endocardial leads with Elgiloy® (#K990483, cleared 06/03/99). » BIOTRONIK's DY unipolar, active fixation, endocardial lead (#K841451/A, cleared 02/07/85). e BIOTRONIK's FH bipolar, active fixation, endocardial lead (#K910608, cleared 07/30/91). e Cardiac Pacem…
Biotronik Sales, Inc.1985—
*K910608Permanent Implantable FH Endocardial Leads W/Tip
Summary page 1
…d 06/03/99). » BIOTRONIK's DY unipolar, active fixation, endocardial lead (#K841451/A, cleared 02/07/85). e BIOTRONIK's FH bipolar, active fixation, endocardial lead (#K910608, cleared 07/30/91). e Cardiac Pacemakers Inc. (CPI) Sweet Tip, bipolar, active fixation, endocardial lead (#K873888, cleared 05/…
Biotronik, GmbH & Co.1991—
Kept off the family treeK873888Cardiac Pacemakers Inc. (CPI) Sweet Tip, bipolar, active fixation, endocardial…
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 1
…IK's FH bipolar, active fixation, endocardial lead (#K910608, cleared 07/30/91). e Cardiac Pacemakers Inc. (CPI) Sweet Tip, bipolar, active fixation, endocardial lead (#K873888, cleared 05/17/88) Indications for Use: BIOTRONIK's YP xx/15-BP leads are indicated for permanent pacing and sensing. Active fi…

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 6 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
  • None of the 5 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 YP xx/15-BP 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. The leads may be used with single or dual chamber pacing systems.

The YP xx/15-BP lead models are intended for placement in either the patient’s 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.

More from Biotronik, Inc.

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

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  • 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/K993139 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993139: YP 45/15-BP; YP 53/15-BP; YP 60/15-BP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993139

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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