510(k) Report

510(k) · Cleared

Cleared

Redi-Release Absorbent Dressing

K904604510(k) TraditionalCleared Jan 7, 199189-day reviewClass I21 CFR 878.4018

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

Fountain Pharmaceuticals, Inc. · KOZ Beads, Hydrophilic, For Wound Exudate Absorption

Cleared on Jan 7, 1991 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 7, 1991
Review
89 days
Class
Class I
Product code
KOZ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K904604Source: 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 KOZ? 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 KOZ devices

KOZ Beads, Hydrophilic, For Wound Exudate Absorption: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KOZ

FDA has decided no KOZ device since 2007.

Median 510(k) review, days · KOZ

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

Recalls per year · KOZ

No recall names KOZ since 2007.

Adverse event reports per year · KOZ

2in 2024

2014: 12016: 32017: 52018: 22019: 12024: 2
2007high 5 (2017) · low 0 (2007)2025

MAUDE reports naming product code KOZ, 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—00
20110—00
20120—00
20130—00
20140—01
20150—00
20160—03
20170—05
20180—02
20190—01
20200—00
20210—00
20220—00
20230—00
20240—02
20250—00
20260—0—

More from Fountain Pharmaceuticals, Inc.

2 FDA decisions under this applicant name. See the company

  • K895654Sorbex (TM) Soft SpongeFountain Pharmaceuticals, Inc. · 1990

Recent decisions in KOZ

The KOZ category page

  • K905206Incare Pinsite DressingHollister, Inc. · 1991
  • K905688Cutinova HydroBeiersdorf, Inc. · 1991
  • K905069Iodosorb GelPerstorp AB C/O Robert Joel Slomoff · 1991
  • K903645Dermasorb Wound Contact Layer DressingConvatec, A Division of E.R. Squibb & Sons · 1990
  • K896828Bioclusive (R) Absorbent DressingJohnson & Johnson International · 1990

https://510kreport.com/device/K904604 · printed Nov 3, 2026

Cite this page

510(k) Report. “K904604: Redi-Release Absorbent Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K904604

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