510(k) Report

510(k) · Cleared

Cleared

Merox Bipolar High Impedance Lead Models: Mex 53/13-BP; 60/15-BP; 45-JBP; 53-JBP

K010281510(k) TraditionalCleared Apr 9, 2002434-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 Apr 9, 2002 after a 434-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Apr 9, 2002
Review
434 days
Class
Class III
Product code
DTB
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 2 descendants cleared200020052010201520202025
  1. This deviceK010281 Merox Bipolar High Impedance Lead Models: Mex 53/13-BP; 60/15-BP…Biotronik, Inc. · 2002
  2. Descendant · cites it directly · 1 of its ownK021217 Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBPBiotronik, Inc. · 2002
  3. 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 2 of 2 · See all
  • K021217Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBPBiotronik, Inc. · 2002 · cites it directly1descendant
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010281Merox Bipolar High Impedance Lead Models: Mex 53/13-BP; 60/15-BP; 45-JBP; 53-JBPBiotronik, Inc.2002—
+1K021217Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBPBiotronik, Inc.2002—
+1K023099Arox 45-JBP; Arox 53-JBP; Merox 45-JBP; Merox 53-JBPBiotronik, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
FIG. 1 — Lineage of K010281, 2002–2002Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K021217Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBPBiotronik, Inc.20021
K023099Arox 45-JBP; Arox 53-JBP; Merox 45-JBP; Merox 53-JBPBiotronik, Inc.20020

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, K021217 (Biotronik, Inc., 2002) 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—

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Recent decisions in DTB

The DTB category page

https://510kreport.com/device/K010281 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010281: Merox Bipolar High Impedance Lead Models: Mex 53/13-BP; 60/15-BP; 45-JBP; 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/K010281

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026