510(k) · Cleared

Cleared

Silon Dual-Dress

K990042510(k) TraditionalCleared Mar 19, 199972-day reviewClass U

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

Bio Med Sciences, Inc. · FRO Dressing, Wound, Drug

Cleared on Mar 19, 1999 as substantially equivalent to K912032 (Bio Med Sciences, Inc., 1991) and 2 other predicates after a 72-day review. Its family tree reaches back 1 generation to 1991.

Decided: Mar 19, 1999
Review: 72 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K912032 (1991). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK912032 Silon (TM) Transparent Wound DressingBio Med Sciences, Inc. · 1991
This deviceK990042 Silon Dual-DressBio Med Sciences, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K912032	Silon (TM) Transparent Wound Dressing	Bio Med Sciences, Inc.	1991	—
0 (this device)	K990042	Silon Dual-Dress	Bio Med Sciences, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1997	1	0

FIG. 1 — Lineage of K990042, 1991–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FRO device

#1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K912032	Silon (TM) Transparent Wound Dressing Summary page 1 …NCE Bio Med Sciences claims substantial equivalency for Silon® Dual-Dress™ to the following devices: 1. Silon Transparent Wound Dressings (Bio Med Sciences, Inc. 510K #s K912032 & K923150) 2. Epitec® Dressing (Rynel Ltd, Inc. 510K #K971337) 4, sf' ~/¢ DEPARTMENT OF HEALTH & HUMAN SERVICES P…	Bio Med Sciences, Inc.	1991	—
*	K923150	Silon Transparent Wound Dressings Summary page 1 …d Sciences claims substantial equivalency for Silon® Dual-Dress™ to the following devices: 1. Silon Transparent Wound Dressings (Bio Med Sciences, Inc. 510K #s K912032 & K923150) 2. Epitec® Dressing (Rynel Ltd, Inc. 510K #K971337) 4, sf' ~/¢ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Heal…	Bio Med Sciences, Inc.	1992	—
*	K971337	Epitech Island Dressings Summary page 1 …Dual-Dress™ to the following devices: 1. Silon Transparent Wound Dressings (Bio Med Sciences, Inc. 510K #s K912032 & K923150) 2. Epitec® Dressing (Rynel Ltd, Inc. 510K #K971337) 4, sf' ~/¢ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service S o, ”% - - Food and Drug Administratio…	Rynel, Ltd. Inc.	1997	—

Also cleared against K912032: 1 other device →

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.

What does this lineage say?

None of the 3 ancestors has a recall.
1 other device also cites its predicate K912032.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRO

11in 2025

2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007high 332 (2022) · low 96 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRO

2in 2024

2007high 6 (2021) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · FRO

192in 2025

2007high 297 (2015) · low 30 (2008)2025

MAUDE reports naming product code FRO, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	29	187	4	55
2008	26	130	1	30
2009	31	136	1	45
2010	31	146	0	122
2011	27	177	4	42
2012	24	96	0	65
2013	19	194	1	139
2014	22	214	1	269
2015	28	249	2	297
2016	28	222	3	147
2017	23	147	1	149
2018	20	206	0	128
2019	16	270	1	136
2020	12	226	0	139
2021	8	275	6	183
2022	9	332	2	176
2023	18	283	2 (2)	198
2024	24	263	2	232
2025	11	176	0	192
2026	17	254	2	—

What is it indicated for?

For the management of partial and full thickness wounds including the following:

Second Degree Burns

Skin Graft Donor Sites

Autograft Sites

Abrasions

Lacerations

Stage II - III Chronic Wounds (Venous Stasis, Decubitus & Diabetic)

Skin Tears

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K990042 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990042: Silon Dual-Dress.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990042

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026