510(k) Report

510(k) · Cleared

Cleared

SR-Isocette

K811665510(k) TraditionalCleared Jul 15, 198130-day reviewClass I21 CFR 872.3910

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

J. Aderer, Inc. · ELK Teeth, Artificial, Backing And Facing

Cleared on Jul 15, 1981 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 15, 1981
Review
30 days
Class
Class I
Product code
ELK
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K811665Source: 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 ELK devices

ELK Teeth, Artificial, Backing And Facing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ELK

FDA has decided no ELK device since 2007.

Median 510(k) review, days · ELK

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

Recalls per year · ELK

No recall names ELK since 2007.

Adverse event reports per year · ELK

No MAUDE report names ELK 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 J. Aderer, Inc.

24 FDA decisions under this applicant name. See the company

  • K822957PurcastJ. Aderer, Inc. · 1982
  • K822956G CASTJ. Aderer, Inc. · 1982
  • K82179882 ALLOYJ. Aderer, Inc. · 1982
  • K821832Degucast UJ. Aderer, Inc. · 1982
  • K821590Pors-onJ. Aderer, Inc. · 1982

Recent decisions in ELK

The ELK category page

  • K760909Thermometer Jars and CapsPlastics/Packaging · 1976

https://510kreport.com/device/K811665 · printed Nov 6, 2026

Cite this page

510(k) Report. “K811665: SR-Isocette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K811665

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