510(k) · Cleared
ClearedArox 45-JBP; Arox 53-JBP; Merox 45-JBP; Merox 53-JBP
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 Oct 18, 2002 as substantially equivalent to K021217 (Biotronik, Inc., 2002) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Oct 18, 2002
- Review
- 30 days
- Class
- Class III
- Product code
- DTB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000763 (2000). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK000763 PX 53/15-BP, Model 130 050 and PX 60/15-BP, Model 130 051Biotronik, GmbH & Co. · 2000
- 1 generation backK021217 Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBPBiotronik, Inc. · 2002
- This deviceK023099 Arox 45-JBP; Arox 53-JBP; Merox 45-JBP; Merox 53-JBPBiotronik, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000763 | PX 53/15-BP, Model 130 050 and PX 60/15-BP, Model 130 051 | Biotronik, GmbH & Co. | 2000 | — |
| −1 | K021217 | Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBP | Biotronik, Inc. | 2002 | — |
| 0 (this device) | K023099 | Arox 45-JBP; Arox 53-JBP; Merox 45-JBP; Merox 53-JBP | Biotronik, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K021217 | Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBPSummary page 1…traight and “J“-shaped configurations, for placement in the ventricle or atrium. The Arox and Merox lead families have been approved by FDA for distribution in the U.S. (K021217, dated 05-01-02 and #K010281, dated 04-09-02, respectively). The designations Arox xx-JBP and Merox xx-JBP refer to “J”-shaped le… | 2002 |
| * | K010281 | Merox Bipolar High Impedance Lead Models: Mex 53/13-BP; 60/15-BP; 45-JBP; 53-JBPSummary page 1…urations, for placement in the ventricle or atrium. The Arox and Merox lead families have been approved by FDA for distribution in the U.S. (K021217, dated 05-01-02 and #K010281, dated 04-09-02, respectively). The designations Arox xx-JBP and Merox xx-JBP refer to “J”-shaped leads, which are available in l… | 2002 |
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 2 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- None of the 3 ancestors has a recall.
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?
Arox and Merox bipolar, passive-fixation, endocardial pacing leads are intended to provide permanent pacing and sensing in the atrium and/or ventricle when used with a compatible pulse generator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023099: Arox 45-JBP; Arox 53-JBP; Merox 45-JBP; Merox 53-JBP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023099
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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