510(k) Report

510(k) · Cleared

Cleared

Fungus Fighter Insoles

K780719510(k) TraditionalCleared Oct 10, 1978162-day reviewClass I21 CFR 880.6280

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

Combe, Inc. · KYS Insoles, Medical

Cleared on Oct 10, 1978 after a 162-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 10, 1978
Review
162 days
Class
Class I
Product code
KYS
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K780719Source: 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 KYS? 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 KYS devices

KYS Insoles, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KYS

FDA has decided no KYS device since 2007.

Median 510(k) review, days · KYS

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

Recalls per year · KYS

No recall names KYS since 2007.

Adverse event reports per year · KYS

9in 2025

2010: 12011: 12017: 12018: 62019: 12021: 12022: 12023: 22024: 42025: 9
2007high 9 (2025) · low 0 (2007)2025

MAUDE reports naming product code KYS, 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—00
20080—00
20090—00
20100—01
20110—01
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—06
20190—01
20200—00
20210—01
20220—01
20230—02
20240—04
20250—09
20260—0—

More from Combe, Inc.

6 FDA decisions under this applicant name. See the company

  • K942203Otc Denture CleanserCombe, Inc. · 1994
  • K925259CFR MonographCombe, Inc. · 1993
  • K863375Sea-BondCombe, Inc. · 1986
  • K770413Cushions, Denture Adhesive, All-DayCombe, Inc. · 1977
  • K770175Sea-Bond Adhevise Denture CushionsCombe, Inc. · 1977

https://510kreport.com/device/K780719 · printed Nov 6, 2026

Cite this page

510(k) Report. “K780719: Fungus Fighter Insoles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K780719

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