510(k) Report

510(k) · Cleared

Cleared

Bioclusive MVP Transparent Dressing

K923235510(k) TraditionalCleared May 12, 1993315-day reviewClass I21 CFR 880.5240

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

Johnson & Johnson Medical, Inc. · KGX Tape And Bandage, Adhesive

Cleared on May 12, 1993 after a 315-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
May 12, 1993
Review
315 days
Class
Class I
Product code
KGX
Recalls
None
Predicates
0

5 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2002: 1 descendant cleared2005: 1 descendant cleared2009: 1 descendant cleared2006: 1 descendant cleared1990200020102020
  1. This deviceK923235 Bioclusive MVP Transparent DressingJohnson & Johnson Medical, Inc. · 1993
  2. Descendant · cites it directly · 4 of its ownK991214 Simplicare Transparent Wound DressingHollister, Inc. · 1999
  3. Descendant · 2 generations on · 3 of its ownK020781 Wet ChamberKinetic Concepts, Inc. · 2002
  4. Descendant · 3 generations on · 1 of its ownK060046 DermastreamEnzysurge, Ltd. · 2006
  5. Descendant · 3 generations on · 0 of its ownK091133 Aplion Topical Care SystemAplion Medical,Llc · 2009
  6. Descendant · 3 generations on · 0 of its ownK043063 Oxyband Wound DressingOxyband Technologies, Inc. · 2005

Most influential descendants

Showing 5 of 5 · See all
  • K991214Simplicare Transparent Wound DressingHollister, Inc. · 1999 · cites it directly4descendants
  • K020781Wet ChamberKinetic Concepts, Inc. · 2002 · 2 generations on3descendants
  • K060046DermastreamEnzysurge, Ltd. · 2006 · 3 generations on1descendant
  • K091133Aplion Topical Care SystemAplion Medical,Llc · 2009 · 3 generations on0descendants
  • K043063Oxyband Wound DressingOxyband Technologies, Inc. · 2005 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K923235Bioclusive MVP Transparent DressingJohnson & Johnson Medical, Inc.1993—
+1K991214Simplicare Transparent Wound DressingHollister, Inc.1999—
+2K020781Wet ChamberKinetic Concepts, Inc.2002—
+3K060046DermastreamEnzysurge, Ltd.2006—
+3K091133Aplion Topical Care SystemAplion Medical,Llc2009—
+3K043063Oxyband Wound DressingOxyband Technologies, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200210
200510
200610
200910
FIG. 1 — Lineage of K923235, 1993–2009Source: FDA 510(k) summaries, read by 510(k) Report · 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 KGX? 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? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K991214Simplicare Transparent Wound DressingHollister, Inc.19994

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.

What does this lineage say?

  • Of its descendants, K991214 (Hollister, Inc., 1999) has gone furthest, with 4 descendants of its own.

How does its category compare?

All KGX devices

KGX Tape And Bandage, Adhesive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGX

FDA has decided no KGX device since 2007.

Median 510(k) review, days · KGX

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

Recalls per year · KGX

8in 2025

2010: 82011: 42012: 22015: 32019: 12025: 8
2007high 8 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KGX

317in 2025

2007: 372008: 262009: 372010: 312011: 392012: 592013: 882014: 982015: 2002016: 1582017: 2062018: 2132019: 4882020: 1,2902021: 5622022: 2532023: 1922024: 2242025: 317
2007high 1,290 (2020) · low 26 (2008)2025

MAUDE reports naming product code KGX, 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—037
20080—026
20090—037
20100—831
20110—439
20120—259
20130—088
20140—098
20150—3200
20160—0158
20170—0206
20180—0213
20190—1488
20200—01,290
20210—0562
20220—0253
20230—0192
20240—0224
20250—8317
20260—0—

More from Johnson & Johnson Medical, Inc.

54 FDA decisions under this applicant name. See the company

  • K001690Protectiv Safety Blood Collection NeedleJohnson & Johnson Medical, Inc. · 2000
  • K982641Advanced Nibp ModuleJohnson & Johnson Medical, Inc. · 1999
  • K983362NU-Gel * Wound DressingJohnson & Johnson Medical, Inc. · 1998
  • K982597Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
  • K974080Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 19981 recall

Recent decisions in KGX

The KGX category page

  • K001240Seragard Injection PatchPlatinum Services, Inc. · 2000
  • K983368Care Band Antibacterial BandagesAso Corp. · 1999
  • K972914Syvek PatchMarine Polymer Technologies, Inc. · 1997
  • K943314Adhesive Bandages with Otc DrugJohnson & Johnson Consumer Products, Inc. · 1996
  • K952606Targett PatchCutting Edge Technologies, Inc. · 1995

https://510kreport.com/device/K923235 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923235: Bioclusive MVP Transparent Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923235

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