510(k) Report

510(k) · Cleared

Cleared

Vitachoice Wound Dressing

K896455510(k) TraditionalCleared Feb 15, 199098-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

Vitaphore Corp. · KGX Tape And Bandage, Adhesive

Cleared on Feb 15, 1990 after a 98-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 54 later devices descend from it.

Decided
Feb 15, 1990
Review
98 days
Class
Class I
Product code
KGX
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant cleared2009: 2 descendants cleared2007: 1 descendant cleared2008: 2 descendants cleared2013: 2 descendants cleared2010: 3 descendants cleared2026: 8 descendants cleared2011: 1 descendant cleared2022: 5 descendants cleared2012: 1 descendant cleared2017: 4 descendants cleared2021: 1 descendant cleared2023: 4 descendants cleared2016: 2 descendants cleared2019: 1 descendant cleared2018: 1 descendant cleared2024: 7 descendants cleared2020: 2 descendants cleared2025: 4 descendants cleared1990200020102020
  1. This deviceK896455 Vitachoice Wound DressingVitaphore Corp. · 1990
  2. Descendant · cites it directly · 53 of its ownK021792 Bilayer Matrix Wound DressingIntegra Lifesciences Corp. · 2002 · Recalled
  3. Descendant · 2 generations on · 19 of its ownK092096 Endoform Dermal TemplateMesynthes, Ltd. · 2010 · Recalled
  4. Descendant · 2 generations on · 10 of its ownK132397 Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014
  5. Descendant · 2 generations on · 10 of its ownK081635 Integra Meshed Bilayer Wound MatrixIntegra Lifesciences Corp. · 2008
  6. Descendant · 2 generations on · 5 of its ownK142879 BTM Wound DressingPolynovo Biomaterials Pty, Ltd. · 2015

Showing 5 of 54 descendants. See all descendants

Descendants cleared per year

2002: 12007: 12008: 22009: 22010: 32011: 12012: 12013: 22014: 12015: 12016: 22017: 42018: 12019: 12020: 22021: 12022: 52023: 42024: 72025: 42026: 8
2002high 8 (2026) · low 0 (2003)2026

Most influential descendants

Showing 5 of 54 · See all
  • K021792Bilayer Matrix Wound DressingIntegra Lifesciences Corp. · 2002 · cites it directly53descendants
  • K092096Endoform Dermal TemplateMesynthes, Ltd. · 2010 · 2 generations on19descendants
  • K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014 · 2 generations on10descendants
  • K081635Integra Meshed Bilayer Wound MatrixIntegra Lifesciences Corp. · 2008 · 2 generations on10descendants
  • K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd. · 2015 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K896455Vitachoice Wound DressingVitaphore Corp.1990—
+1K021792Bilayer Matrix Wound DressingIntegra Lifesciences Corp.20021
+2K092096Endoform Dermal TemplateMesynthes, Ltd.20103
+2K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.2014—
+2K081635Integra Meshed Bilayer Wound MatrixIntegra Lifesciences Corp.2008—
+2K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200710
200820
200920
201030
201110
201210
201320
201410
201510
201620
201740
201810
201910
202020
202110
202250
202340
202470
202540
202680
FIG. 1 — Lineage of K896455, 1990–2026Source: 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? (54)

See all 54

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

NumberDeviceApplicantDecidedDescendants
K021792Bilayer Matrix Wound DressingIntegra Lifesciences Corp.200253

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, K021792 (Integra Lifesciences Corp., 2002) has gone furthest, with 53 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 Vitaphore Corp.

13 FDA decisions under this applicant name. See the company

  • K914579Silver Foam Wound DressingVitaphore Corp. · 1992
  • K913148Collagen Shield for Acute CareVitaphore Corp. · 1991
  • K895920Vitapatch Pin Protection Device for PercutaneousVitaphore Corp. · 1991
  • K902558Collagen Shield for Acute CareVitaphore Corp. · 1990
  • K891993Collagen NeurospongeVitaphore Corp. · 1990

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/K896455 · printed Nov 6, 2026

Cite this page

510(k) Report. “K896455: Vitachoice Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K896455

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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