510(k) Report

510(k) · Cleared

Cleared

SX 53/15-BP, Model 124 853, SX 60/15-BP, Model 124 854

K991169510(k) TraditionalCleared Jul 1, 199985-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 Jul 1, 1999 as substantially equivalent to K980869 (Biotronik, Inc., 1998) after an 85-day review. Its family tree reaches back 1 generation to 1998.

Decided
Jul 1, 1999
Review
85 days
Class
Class III
Product code
DTB
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K980869 (1998). No later device cites it as a predicate yet.

K980869 · Synox SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , Models 120 444, 119 684, 120 438 and 120 143 · Biotronik, Inc. · 1998199619982000
K980869 · Synox SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , Models 120 444, 119 684, 120 438 and 120 143 · Biotronik, Inc. · 19980
  1. Root · 1 generation backK980869 Synox SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , Models 120 444, 119…Biotronik, Inc. · 1998
  2. This deviceK991169 SX 53/15-BP, Model 124 853, SX 60/15-BP, Model 124 854Biotronik, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K980869Synox SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , Models 120 444, 119 684, 120…Biotronik, Inc.1998—
0 (this device)K991169SX 53/15-BP, Model 124 853, SX 60/15-BP, Model 124 854Biotronik, Inc.1999—
FIG. 1 — Lineage of K991169, 1998–1999Source: 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? (1)

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
*K980869Synox SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , Models 120 444, 119 684, 120 438 and…
Summary page 1
…n this 510(k) notification are modified versions of BIOTRONIK's currently marketed straight Synox leads (SX 53-BP and SX 60-BP) approved September 10, 1998 under 510(k) #K980869. The modification is a reduction of the distance between the ring and tip electrodes from 31 mm to 15 mm. Because of this change,…
Biotronik, Inc.1998—

Also cleared against K980869: 2 other devices →

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?

  • Its one ancestor has no recall.
  • 2 other devices also cite its predicate K980869.

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?

Synox leads are designed for use with implantable pulse generators that require pacing leads with a bipolar 3.2 mm IS-1 connector configuration; they may be used with single or dual chamber pacing systems. The leads are designed for use in patients for whom single or dual chamber pulse generator therapy is medically indicated. This indication follows that recommended in the Class | definition of the ACC/AHA Task Force Report, entitled “Guidelines for Implantation of Cardiac Pacemakers and Antiarrhythmic Devices” (JACC, Vol. 18, No. 1, July 1991:1 - 13).

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 K980869

2 other devices cite the same predicate.

  • K023205Elox P 45-BP; Elox P 53-BP; Elox P 60-BPBiotronik, Inc. · 2003
  • K994240EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133Biotronik, Inc. · 2000

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/K991169 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991169: SX 53/15-BP, Model 124 853, SX 60/15-BP, Model 124 854.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991169

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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