510(k) · Cleared
ClearedRetrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · DTB Permanent Pacemaker Electrode
Cleared on Jun 3, 1999 as substantially equivalent to K981083 (Biotronik, Inc., 1998) and 1 other predicate after a 107-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Jun 3, 1999
- Review
- 107 days
- Class
- Class III
- Product code
- DTB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920662 (1993). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K993139YP 45/15-BP; YP 53/15-BP; YP 60/15-BPBiotronik, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920662 | Vascotwist 9/60 | Vascor Medical Corp. | 1993 | — |
| 0 (this device) | K990483 | Retrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 | Biotronik, Inc. | 1999 | — |
| +1 | K993139 | YP 45/15-BP; YP 53/15-BP; YP 60/15-BP | Biotronik, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
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
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981083 | Retrox RX 53-BP, Retrox RX 60-BP, Retrox RX 45-JBP, Retrox RX 53-JBP Model Numbers 124…Summary page 1…K obtained clearance to commercially distribute the Retrox Active-Fixation Endocardial Lead on July 22, 1998 after determination of substantial equivalence under 510(k) #K981083. The Retrox lead being introduced in this 510(k) notification is identical to the Retrox lead already cleared for distribution wi… | 1998 |
| * | K920662 | Vascotwist 9/60Summary page 1…ured with an alloy containing 70% platinum/30% iridium. With regard to the Retrox lead’s new active fixation material, the VascoTwist 9/60 series of endocardial leads (#K920662, dated 11/24/93) is the predicate device to which the Retrox lead with Elgiloy is substantially equivalent. Indications for Use:… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993139 | YP 45/15-BP; YP 53/15-BP; YP 60/15-BP | 1999 | 0 |
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?
How does its category compare?
All DTB devicesDTB Permanent Pacemaker Electrode: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTB
1in 2025
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTB
25,591in 2025
MAUDE reports naming product code DTB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 5,401 |
| 2008 | 0 | — | 1 | 6,469 |
| 2009 | 0 | — | 2 | 7,565 |
| 2010 | 0 | — | 2 | 14,285 |
| 2011 | 0 | — | 0 | 12,555 |
| 2012 | 0 | — | 0 | 12,230 |
| 2013 | 0 | — | 0 | 10,102 |
| 2014 | 0 | — | 0 | 13,324 |
| 2015 | 3 | — | 1 | 11,071 |
| 2016 | 8 | — | 0 | 11,839 |
| 2017 | 5 | — | 0 | 11,495 |
| 2018 | 6 | — | 0 | 15,209 |
| 2019 | 7 | — | 0 | 16,812 |
| 2020 | 6 | — | 0 | 17,859 |
| 2021 | 3 | — | 0 | 18,442 |
| 2022 | 4 | — | 0 | 19,444 |
| 2023 | 7 | — | 0 | 34,542 |
| 2024 | 3 | — | 0 | 25,689 |
| 2025 | 1 | — | 0 | 25,591 |
| 2026 | 2 | — | 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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990483 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990483: Retrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990483
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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