510(k) Report

510(k) · Decided

Decided

Kit Pak Incontinent Skin Care Kit

K932310510(k) TraditionalDecided Jun 1, 1994386-day reviewClass I21 CFR 876.5920

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

Kit Pak, Inc. · EYQ Garment, Protective, For Incontinence

Cleared on Jun 1, 1994 after a 386-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jun 1, 1994
Review
386 days
Class
Class I
Product code
EYQ
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K932310Source: 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 lists a 510(k) statement for it but has not posted the file, 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 EYQ devices

EYQ Garment, Protective, For Incontinence: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EYQ

FDA has decided no EYQ device since 2007.

Median 510(k) review, days · EYQ

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

Recalls per year · EYQ

No recall names EYQ since 2007.

Adverse event reports per year · EYQ

5in 2025

2007: 22009: 32010: 32011: 12012: 92013: 132014: 112015: 112016: 62017: 82018: 202019: 282020: 42021: 52022: 52023: 82024: 72025: 5
2007high 28 (2019) · low 0 (2008)2025

MAUDE reports naming product code EYQ, 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—02
20080—00
20090—03
20100—03
20110—01
20120—09
20130—013
20140—011
20150—011
20160—06
20170—08
20180—020
20190—028
20200—04
20210—05
20220—05
20230—08
20240—07
20250—05
20260—0—

More from Kit Pak, Inc.

13 FDA decisions under this applicant name. See the company

  • K942959Kit Pak Wet Saline DressingKit Pak, Inc. · 1995
  • K941499Kit Pak Dressing Change TrayKit Pak, Inc. · 1994
  • K934080Urinary Drainage BagKit Pak, Inc. · 1994
  • K931013Foley Catheter TrayKit Pak, Inc. · 1993
  • K923905Wound Dressing KitKit Pak, Inc. · 1993

Recent decisions in EYQ

The EYQ category page

  • K950784Dristar Urinary Incontinence Management SystemAdvanced Bioresearch Assoc. · 1995
  • K903342Deodorizing and Sound Muffling Anal PadBiological Resistance, Inc. · 1990
  • K891686Lib System, Baby/Adult DiaperIntera Corp. · 1989
  • K885185Intera Shield and Intera UndergarmentIntera Corp. · 1989
  • K883894Dripride Provide SlimWeyerhaeuser Co. · 1989

https://510kreport.com/device/K932310 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932310: Kit Pak Incontinent Skin Care Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932310

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