510(k) Report

510(k) · Cleared

Cleared

Irrivage

K922785510(k) TraditionalCleared Oct 16, 1992129-day reviewClass I21 CFR 878.4014

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

Autovage · EYF Protector, Wound, Plastic

Cleared on Oct 16, 1992 after a 129-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Oct 16, 1992
Review
129 days
Class
Class I
Product code
EYF
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K922785Source: 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), 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.

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  • 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?

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 EYF devices

EYF Protector, Wound, Plastic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EYF

FDA has decided no EYF device since 2007.

Median 510(k) review, days · EYF

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

Recalls per year · EYF

No recall names EYF since 2007.

Adverse event reports per year · EYF

No MAUDE report names EYF 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 Autovage

7 FDA decisions under this applicant name. See the company

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  • K832908Comfeel Protective RingsColoplast A/S · 1983

https://510kreport.com/device/K922785 · printed Nov 6, 2026

Cite this page

510(k) Report. “K922785: Irrivage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922785

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026