510(k) · Cleared

Cleared

Cicacare Roll-on Gel-Scar Management Liquid Gel.

K991968510(k) TraditionalCleared Jul 30, 199949-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

Smith & Nephew, Inc. · MDA Elastomer, Silicone, For Scar Management

Cleared on Jul 30, 1999 as substantially equivalent to K954413 (Allied Biomedical Corp., 1995) and 2 other predicates after a 49-day review. Its family tree reaches back 2 generations to 1990.

Decided: Jul 30, 1999
Review: 49 days
Class: Class I
Product code: MDA
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K894226 (1990). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK894226 Silastic Soft SheetingDow Corning Wright · 1990
1 generation backK960254 Silgel Topical Gel SheetRofil Medical USA, Inc. · 1996
This deviceK991968 Cicacare Roll-on Gel-Scar Management Liquid Gel.Smith & Nephew, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K894226	Silastic Soft Sheeting	Dow Corning Wright	1990	—
−1	K960254	Silgel Topical Gel Sheet	Rofil Medical USA, Inc.	1996	—
0 (this device)	K991968	Cicacare Roll-on Gel-Scar Management Liquid Gel.	Smith & Nephew, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1998	1	0

FIG. 1 — Lineage of K991968, 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

Get a 510(k) Report

What was it cleared against? (4)

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
*	K954413	Kelocote Summary page 1 …components do not contain animal ingredients. Substantially equivalent products are contained in the following matrix. Product 510(K) Kelocote Allied Bio- Medical Corp K954413 Silgel Biosil Ltd. K960254 Rejuveness Rickmark International K974380 Corp. Clinicel Life Medical Sciences, Inc. 510/cica care ro…	Allied Biomedical Corp.	1995	—
*	K960254	Silgel Topical Gel Sheet Summary page 1 …nimal ingredients. Substantially equivalent products are contained in the following matrix. Product 510(K) Kelocote Allied Bio- Medical Corp K954413 Silgel Biosil Ltd. K960254 Rejuveness Rickmark International K974380 Corp. Clinicel Life Medical Sciences, Inc. 510/cica care roll on gel 510K summary.doc…	Rofil Medical USA, Inc.	1996	—
*	K974380	Rejuveness Summary page 1 …nt products are contained in the following matrix. Product 510(K) Kelocote Allied Bio- Medical Corp K954413 Silgel Biosil Ltd. K960254 Rejuveness Rickmark International K974380 Corp. Clinicel Life Medical Sciences, Inc. 510/cica care roll on gel 510K summary.doc June 10, 1999 Public Healt…	Rejuveness Pharamceuticals, Inc.	1998	—
*	—	Clinicel Named without a submission number			—

Also cleared against K954413: 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?

The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
None of the 4 ancestors has a recall.
1 other device also cites its predicate K954413.

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?

* The device is intended for the management of hypertrophic and keloid scars.

* The device may prevent the formation of hypertrophic and keloid scars.

* The product is indicated for use only on intact skin.

* For application to Hypertrophic and Keloid Scars as a means of reducing the size and erythema of scars resulting from burns, trauma and surgery.

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/K991968 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991968: Cicacare Roll-on Gel-Scar Management Liquid Gel..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991968

Report an extraction error

Are you the manufacturer?

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