510(k) · Cleared

Cleared

Qualtex Island Dressing

K910657510(k) TraditionalCleared Jul 1, 1991137-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

Deroyal Industries, Inc. · KGX Tape And Bandage, Adhesive

Cleared on Jul 1, 1991 after a 137-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 36 later devices descend from it.

Decided: Jul 1, 1991
Review: 137 days
Class: Class I
Product code: KGX
Recalls: None
Predicates: 0

36 later devices descend from it, 2 citing it directly.

This deviceK910657 Qualtex Island DressingDeroyal Industries, Inc. · 1991
Descendant · cites it directly · 21 of its ownK023609 Silverlon Adhesive StripArgentum International, LLC · 2003
Descendant · cites it directly · 14 of its ownK984208 Silverlon Island Dressing, Silverlon Island PadArgentum International, LLC · 1999
Descendant · 2 generations on · 13 of its ownK122817 Silverlon Island Wound DressingArgentum Medical, LLC · 2014
Descendant · 2 generations on · 9 of its ownK033587 SilversealNoble Fiber Technologies · 2004
Descendant · 2 generations on · 6 of its ownK082333 Asap Wound Dressing GelAmerican Biotech Labs · 2009

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

1999high 6 (2014) · low 0 (2000)2026

Most influential descendants

Showing 5 of 36 · See all

K023609Silverlon Adhesive StripArgentum International, LLC · 2003 · cites it directly21descendants
K984208Silverlon Island Dressing, Silverlon Island PadArgentum International, LLC · 1999 · cites it directly14descendants
K122817Silverlon Island Wound DressingArgentum Medical, LLC · 2014 · 2 generations on13descendants
K033587SilversealNoble Fiber Technologies · 2004 · 2 generations on9descendants
K082333Asap Wound Dressing GelAmerican Biotech Labs · 2009 · 2 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K910657	Qualtex Island Dressing	Deroyal Industries, Inc.	1991	—
+1	K023609	Silverlon Adhesive Strip	Argentum International, LLC	2003	—
+1	K984208	Silverlon Island Dressing, Silverlon Island Pad	Argentum International, LLC	1999	—
+2	K122817	Silverlon Island Wound Dressing	Argentum Medical, LLC	2014	—
+2	K033587	Silverseal	Noble Fiber Technologies	2004	—
+2	K082333	Asap Wound Dressing Gel	American Biotech Labs	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2003	1	0
2004	3	0
2005	2	0
2007	2	0
2009	5	0
2010	1	0
2014	6	0
2015	2	0
2017	1	0
2018	2	0
2019	2	0
2022	1	0
2023	2	0
2024	5	0

FIG. 1 — Lineage of K910657, 1991–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

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? (36)

See all 36

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K023609	Silverlon Adhesive Strip	Argentum International, LLC	2003	21
K984208	Silverlon Island Dressing, Silverlon Island Pad	Argentum International, LLC	1999	14

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, K023609 (Argentum International, LLC, 2003) has gone furthest, with 21 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

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

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

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	37
2008	—	0	26
2009	—	0	37
2010	—	8	31
2011	—	4	39
2012	—	2	59
2013	—	0	88
2014	—	0	98
2015	—	3	200
2016	—	0	158
2017	—	0	206
2018	—	0	213
2019	—	1	488
2020	—	0	1,290
2021	—	0	562
2022	—	0	253
2023	—	0	192
2024	—	0	224
2025	—	8	317
2026	—	0	—

https://510kreport.com/device/K910657 · printed Nov 3, 2026

Cite this page

510(k) Report. “K910657: Qualtex Island Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K910657

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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