510(k) Report

510(k) · Cleared

Cleared

Sterile Film Wound Dressing

K924008510(k) TraditionalCleared Nov 24, 1992106-day reviewClass U

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

Innovative Technology, Ltd. · MGP Dressing, Wound And Burn, Occlusive

Cleared on Nov 24, 1992 after a 106-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 24, 1992
Review
106 days
Class
Class U
Product code
MGP
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K924008Source: 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 MGP? 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 MGP devices

MGP Dressing, Wound And Burn, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MGP

FDA has decided no MGP device since 2007.

Median 510(k) review, days · MGP

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

Recalls per year · MGP

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MGP

8in 2024

2007: 12009: 12010: 22011: 42013: 72014: 12015: 32016: 12017: 62021: 522022: 32023: 32024: 8
2007high 52 (2021) · low 0 (2008)2025

MAUDE reports naming product code MGP, 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—01
20080—00
20090—01
20100—02
20110—14
20120—00
20130—07
20140—01
20150—03
20160—01
20170—06
20180—00
20190—00
20200—00
20210—052
20220—03
20230—03
20240—08
20250—00
20260—0—

More from Innovative Technology, Ltd.

2 FDA decisions under this applicant name. See the company

  • K930151Omni-MatrixInnovative Technology, Ltd. · 1993

Recent decisions in MGP

The MGP category page

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  • K012995Collatek SheetBiocore Medical Technologies, Inc. · 2001
  • K001508Laserskin DressingFidia Advanced Biopolymers Srl · 2001
  • K990079Fastseal Chest Wound DressingGreenfield Medical Technologies, Inc. · 1999
  • K991214Simplicare Transparent Wound DressingHollister, Inc. · 1999

https://510kreport.com/device/K924008 · printed Nov 4, 2026

Cite this page

510(k) Report. “K924008: Sterile Film Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924008

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