510(k) Report

510(k) · Cleared

Cleared

Ceravital Ceramic Ear Canal Wall Prosth

K813224510(k) TraditionalCleared Apr 21, 1982163-day reviewClass II21 CFR 878.3500

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

Xomed, Inc. · ESF Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent

Cleared on Apr 21, 1982 after a 163-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 21, 1982
Review
163 days
Class
Class II
Product code
ESF
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K813224Source: 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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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 ESF devices

ESF Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ESF

FDA has decided no ESF device since 2007.

Median 510(k) review, days · ESF

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

Recalls per year · ESF

No recall names ESF since 2007.

Adverse event reports per year · ESF

No MAUDE report names ESF 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 Xomed, Inc.

82 FDA decisions under this applicant name. See the company

  • K002395Model 30 Classic PneumatonometerXomed, Inc. · 2000
  • K002987Redtronic Xomed Monopolar Energized BladeXomed, Inc. · 2000
  • K002828XPS Nitro SystemXomed, Inc. · 20001 recall
  • K002897Titanium Middle Ear ProsthesesXomed, Inc. · 20001 recall
  • K993653Micro-France Trocars and AccessoriesXomed, Inc. · 2000

Recent decisions in ESF

The ESF category page

  • K891247Behind-the-Ear Hearing Aid Model 404 PP-PCSiemens Hearing Instruments, Inc. · 1989

https://510kreport.com/device/K813224 · printed Nov 4, 2026

Cite this page

510(k) Report. “K813224: Ceravital Ceramic Ear Canal Wall Prosth.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K813224

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