510(k) Report

510(k) · Cleared

Cleared

Explorer Tip

K823914510(k) TraditionalCleared Jan 21, 198324-day reviewClass I21 CFR 872.4565

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

Treace Medical, Inc. · EKB Explorer, Operative

Cleared on Jan 21, 1983 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 21, 1983
Review
24 days
Class
Class I
Product code
EKB
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K823914Source: FDA 510(k) database · 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.

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  • 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?

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.

How does its category compare?

All EKB devices

EKB Explorer, Operative: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EKB

FDA has decided no EKB device since 2007.

Median 510(k) review, days · EKB

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

Recalls per year · EKB

No recall names EKB since 2007.

Adverse event reports per year · EKB

1in 2025

2007: 12016: 12019: 12021: 12023: 12025: 1
2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code EKB, 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—01
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—00
20190—01
20200—00
20210—01
20220—00
20230—01
20240—00
20250—01
20260—0—

More from Treace Medical, Inc.

80 FDA decisions under this applicant name. See the company

  • K883727Bucket Prosthesis PorpTreace Medical, Inc. · 1989
  • K882349Mallet, SurgicalTreace Medical, Inc. · 1988
  • K874779Bipolator 50Treace Medical, Inc. · 1988
  • K873154Treace Magnum Oto-Tool SystemTreace Medical, Inc. · 1987
  • K872000Eye GardTreace Medical, Inc. · 1987

Recent decisions in EKB

The EKB category page

  • K8517241410/1 to 1435/13 Various Probes & ExplorersArtiberia · 1985
  • K821780Beach Explorer NO. 23T.G.Pacific Dental Corp. · 1982

https://510kreport.com/device/K823914 · printed Nov 5, 2026

Cite this page

510(k) Report. “K823914: Explorer Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K823914

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