510(k) Report

510(k) · Cleared

Cleared

Austenal Condensing Instrument

K865025510(k) TraditionalCleared Feb 19, 198758-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

Austenal Dental, Inc. · EKG Condenser, Amalgam And Foil, Operative

Cleared on Feb 19, 1987 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 19, 1987
Review
58 days
Class
Class I
Product code
EKG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K865025Source: 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.

Planning a device in EKG? 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?

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 EKG devices

EKG Condenser, Amalgam And Foil, Operative: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EKG

FDA has decided no EKG device since 2007.

Median 510(k) review, days · EKG

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

Recalls per year · EKG

No recall names EKG since 2007.

Adverse event reports per year · EKG

No MAUDE report names EKG since 2007.

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
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Austenal Dental, Inc.

19 FDA decisions under this applicant name. See the company

  • K890713Overdenture - Stud AttachmentAustenal Dental, Inc. · 1989
  • K883799Base, Denture, Relining, Repairing, Rebasing,ResinAustenal Dental, Inc. · 1988
  • K880875Vitallium Equipoise AlloyAustenal Dental, Inc. · 1988
  • K871849Light Cure Denture GlazeAustenal Dental, Inc. · 1987
  • K872746Vitallium WireAustenal Dental, Inc. · 1987

Recent decisions in EKG

The EKG category page

  • K843901Isostatic CondenserShofu Dental Corp. · 1984
  • K823322Dental Instruments - PluggersMiltex, Inc. · 1982

https://510kreport.com/device/K865025 · printed Nov 6, 2026

Cite this page

510(k) Report. “K865025: Austenal Condensing Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K865025

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