510(k) Report

510(k) · Cleared

Cleared

Wirobond C

K032136510(k) TraditionalCleared Sep 4, 200355-day reviewClass II21 CFR 872.3710

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bego U.S.A. · EJH Alloy, Metal, Base

Cleared on Sep 4, 2003 after a 55-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided
Sep 4, 2003
Review
55 days
Class
Class II
Product code
EJH
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared200020052010201520202025
  1. This deviceK032136 Wirobond CBego U.S.A. · 2003
  2. Descendant · cites it directly · 0 of its ownK123929 Begopal+Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K123929Begopal+Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K032136Wirobond CBego U.S.A.2003—
+1K123929Begopal+Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K032136, 2003–2013Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EJH? 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K123929Begopal+Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO20130

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, K123929 (Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO, 2013) has gone furthest, with 0 descendants of its own.

How does its category compare?

All EJH devices

EJH Alloy, Metal, Base: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EJH

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EJH

Too few EJH 510(k)s in any year since 2007 to give a median.

Recalls per year · EJH

No recall names EJH since 2007.

Adverse event reports per year · EJH

1in 2018

2017: 12018: 1
2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code EJH, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20131—00
20140—00
20150—00
20160—00
20170—01
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
Cite this page

510(k) Report. “K032136: Wirobond C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032136

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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