510(k) · Cleared
ClearedArox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 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 May 1, 2002 as substantially equivalent to K010281 (Biotronik, Inc., 2002) and 1 other predicate after a 14-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- May 1, 2002
- Review
- 14 days
- Class
- Class III
- Product code
- DTB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000763 (2000). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK000763 PX 53/15-BP, Model 130 050 and PX 60/15-BP, Model 130 051Biotronik, GmbH & Co. · 2000
- This deviceK021217 Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBPBiotronik, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK023099 Arox 45-JBP; Arox 53-JBP; Merox 45-JBP; Merox 53-JBPBiotronik, Inc. · 2002
Most influential descendants
Showing 1 of 1 · See all- K023099Arox 45-JBP; Arox 53-JBP; Merox 45-JBP; Merox 53-JBPBiotronik, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000763 | PX 53/15-BP, Model 130 050 and PX 60/15-BP, Model 130 051 | Biotronik, GmbH & Co. | 2000 | — |
| 0 (this device) | K021217 | Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBP | Biotronik, Inc. | 2002 | — |
| +1 | 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 |
Descendants 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 |
|---|---|---|---|
| * | K010281 | Merox Bipolar High Impedance Lead Models: Mex 53/13-BP; 60/15-BP; 45-JBP; 53-JBPSummary page 1…-1 connector. Device Modification: : The Arox leads introduced in this Special 510(k) notification are modified versions of BIOTRONIK's currently marketed Merox leads (#K010281, dated 04-09-02). The modifications are a change in the tip electrode surface area from 1.3 mm?to 3.5 mm? and a change in the sha… | 2002 |
| * | K000763 | PX 53/15-BP, Model 130 050 and PX 60/15-BP, Model 130 051Summary page 1…nted to lenticular. The tip electrode surface area size and shape are identical to BIOTRONIK's currently marketed Polyrox family of passive-fixation, endocardial leads (#K000763, dated 04-06-00). Predicate Devices: BIOTRONIK proposes the following leads cleared through 510(k) notifications as predicate de… | 2000 |
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 |
|---|---|---|---|
| K023099 | Arox 45-JBP; Arox 53-JBP; Merox 45-JBP; Merox 53-JBP | 2002 | 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?
Arox bipolar, passive-fixation, endocardial pacing leads (Arox xx-BP and Arox xx-JBP) are intended to provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator.
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/K021217 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021217: Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021217
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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