510(k) Report

510(k) · Cleared

Cleared

Retrox RX 53-BP, Retrox RX 60-BP, Retrox RX 45-JBP, Retrox RX 53-JBP Model Numbers 124 396, 124 397, 124 395, 124 000

K981083510(k) TraditionalCleared Jul 22, 1998120-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 22, 1998 after a 120-day review. The FDA summary names no predicate by number. 4 later devices descend from it.

Decided
Jul 22, 1998
Review
120 days
Class
Class III
Product code
DTB
Recalls
None
Predicates
0

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

Descendants, by year cleared 2000: 1 descendant cleared1999: 2 descendants cleared2003: 1 descendant clearedReference device: K965106 · Elc 35-UP Model Number 116015 and Elc 54-UP Model Number 115606 · Biotronik, Inc. · 19981995200020052010201520202025
  1. This deviceK981083 Retrox RX 53-BP, Retrox RX 60-BP, Retrox RX 45-JBP, Retrox RX 53-JBP…Biotronik, Inc. · 1998
  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 · cites it directly · 1 of its ownK990483 Retrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777Biotronik, Inc. · 1999
  4. Descendant · 2 generations on · 0 of its ownK023205 Elox P 45-BP; Elox P 53-BP; Elox P 60-BPBiotronik, Inc. · 2003
  5. Descendant · 2 generations on · 0 of its ownK993139 YP 45/15-BP; YP 53/15-BP; YP 60/15-BPBiotronik, Inc. · 1999

Most influential descendants

Showing 4 of 4 · 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
  • K990483Retrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777Biotronik, Inc. · 1999 · 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 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K981083Retrox RX 53-BP, Retrox RX 60-BP, Retrox RX 45-JBP, Retrox RX 53-JBP Model…Biotronik, Inc.1998—
+1K994240EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133Biotronik, Inc.2000—
+1K990483Retrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777Biotronik, Inc.1999—
+2K023205Elox P 45-BP; Elox P 53-BP; Elox P 60-BPBiotronik, Inc.2003—
+2K993139YP 45/15-BP; YP 53/15-BP; YP 60/15-BPBiotronik, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200010
200310
FIG. 1 — Lineage of K981083, 1998–2003Source: 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
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (4)

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
K990483Retrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777Biotronik, Inc.19991

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—

What is it indicated for?

The BIOTRONIK RETROX RX 53/60-BP and RETROX RX 45/53-JBP 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. The leads may be used with single- or dual-chamber pacing systems. RETROX RX-BP and RX-JBP leads differ in the shape of the distal portion of the lead. The…

Read the full statement (150 words)

The BIOTRONIK RETROX RX 53/60-BP and RETROX RX 45/53-JBP 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. The leads may be used with single- or dual-chamber pacing systems.

RETROX RX-BP and RX-JBP leads differ in the shape of the distal portion of the lead. The RX-BP models are intended for placement in the ventricle or atrium and have straight distal ends. The RX-JBP models have a pre-formed J-shaped distal end to facilitate lead placement in the right atrial appendage.

The indications for use of a RETROX lead in combination with a connected cardiac pacemaker follow those recommended in the Class I 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.

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Recent decisions in DTB

The DTB category page

https://510kreport.com/device/K981083 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981083: Retrox RX 53-BP, Retrox RX 60-BP, Retrox RX 45-JBP, Retrox RX 53-JBP Model Numbers 124 396, 124 397, 124 395, 124 000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981083

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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