510(k) · Cleared

Cleared

Neosporin Scar Solution

K024160510(k) TraditionalCleared Mar 17, 200390-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

Warner-Lambert Co. · MDA Elastomer, Silicone, For Scar Management

Cleared on Mar 17, 2003 as substantially equivalent to K982036 (Bio Med Sciences, Inc., 1998) and 1 other predicate after a 90-day review. Its family tree reaches back 3 generations to 1994.

Decided: Mar 17, 2003
Review: 90 days
Class: Class I
Product code: MDA
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K932214 (1994). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK932214 Silon Silicone Gel SheetBio Med Sciences, Inc. · 1994
2 generations backK982036 Silon Scar StripsBio Med Sciences, Inc. · 1998
1 generation backK023136 Oleeva FabricBio Med Sciences, Inc. · 2002
This deviceK024160 Neosporin Scar SolutionWarner-Lambert Co. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K932214	Silon Silicone Gel Sheet	Bio Med Sciences, Inc.	1994	—
−2	K982036	Silon Scar Strips	Bio Med Sciences, Inc.	1998	—
−1	K023136	Oleeva Fabric	Bio Med Sciences, Inc.	2002	—
0 (this device)	K024160	Neosporin Scar Solution	Warner-Lambert Co.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2000	1	0

FIG. 1 — Lineage of K024160, 1994–2003Source: 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? (2)

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
*	K982036	Silon Scar Strips Summary page 1 …e Elastomer Sheeting Classification Name: Elastomer, Silicone, for Scar Management Product Code: MDA Predicate Devices: OleevaB Fabric (K982036), and (KO23 136) Bio Med Sciences, Inc. 1 1 1 1 Hamilton St.…	Bio Med Sciences, Inc.	1998	—
*	K023136	Oleeva Fabric	Bio Med Sciences, Inc.	2002	—

Also cleared against K982036: 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 2 companies; a new generation was cleared every 4.2 years on median.
None of the 5 ancestors has a recall.
1 other device also cites its predicate K982036.

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?

[Trade Name] silicone sheeting is indicated for management of hypertrophic scars and keloids.

Consistent use of [Trade Name] can reduce hypertrophic scarring and keloid formation, resulting from surgical or traumatic injury of the skin.

[Trade Name] may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024160 · printed Nov 3, 2026

Cite this page

510(k) Report. “K024160: Neosporin Scar Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024160

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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