510(k) · Cleared

Cleared

Silgel Topical Gel Sheet

K960254510(k) TraditionalCleared Apr 2, 199676-day reviewClass I21 CFR 878.4025

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

Rofil Medical USA, Inc. · MDA Elastomer, Silicone, For Scar Management

Cleared on Apr 2, 1996 as substantially equivalent to K894226 (Dow Corning Wright, 1990) after a 76-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.

Decided: Apr 2, 1996
Review: 76 days
Class: Class I
Product code: MDA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K894226 (1990). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK894226 Silastic Soft SheetingDow Corning Wright · 1990
This deviceK960254 Silgel Topical Gel SheetRofil Medical USA, Inc. · 1996
Descendant · cites it directly · 0 of its ownK991968 Cicacare Roll-on Gel-Scar Management Liquid Gel.Smith & Nephew, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all

K991968Cicacare Roll-on Gel-Scar Management Liquid Gel.Smith & Nephew, Inc. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K894226	Silastic Soft Sheeting	Dow Corning Wright	1990	—
0 (this device)	K960254	Silgel Topical Gel Sheet	Rofil Medical USA, Inc.	1996	—
+1	K991968	Cicacare Roll-on Gel-Scar Management Liquid Gel.	Smith & Nephew, Inc.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K960254, 1990–1999Source: 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 MDA? 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? (6)

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
*	K894226	Silastic Soft Sheeting Summary page 1 …ed 3. Predicate Devices The predicate devices are all silicone topical gel sheets and include: Spenco Silicone Gelsheet, a pre-enactment device Silastic Soft Sheeting, (K894226) [January 3, 1990] Epi-Derm Silicone Gel Sheeting, [510(k) number unknown) New Beginnings Topical Gel Sheeting, [510(k) number un…	Dow Corning Wright	1990	—
*	—	Spenco Silicone Gelsheet Named without a submission number			—
*	—	Epi-Derm Silicone Gel Sheeting Named without a submission number			—
*	—	New Beginnings Topical Gel Sheeting Named without a submission number			—
*	—	DermaSof, Gel Sheeting Named without a submission number			—
*	—	Cica-Care Adhesive Gel Sheet Named without a submission number			—

Also cleared against K894226: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K991968	Cicacare Roll-on Gel-Scar Management Liquid Gel.	Smith & Nephew, Inc.	1999	0

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?

Its one ancestor has no recall.
Of its descendants, K991968 (Smith & Nephew, Inc., 1999) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K894226.

How does its category compare?

All MDA devices

MDA Elastomer, Silicone, For Scar Management: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MDA

2in 2011

2007high 2 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MDA

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

Recalls per year · MDA

No recall names MDA since 2007.

Adverse event reports per year · MDA

3in 2025

2007high 8 (2023) · low 0 (2008)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	3
2008	0	—	0
2009	1	—	0
2010	0	—	0
2011	2	—	0
2012	0	—	0
2013	0	—	2
2014	0	—	1
2015	0	—	2
2016	0	—	5
2017	0	—	3
2018	0	—	2
2019	0	—	5
2020	0	—	4
2021	0	—	3
2022	0	—	0
2023	0	—	8
2024	0	—	0
2025	0	—	3
2026	0	—	—

What is it indicated for?

Silgel is intended for use in the management of hypertrophic and keloid scars, prophylactic management of healed incisions and as a splint lining insert to relieve friction on newly healed scars.

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/K960254 · printed Nov 5, 2026

Cite this page

510(k) Report. “K960254: Silgel Topical Gel Sheet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960254

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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