510(k) · Cleared
ClearedMedtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp. 2ND Skin Silicone Scar Therapy Gel, Model 09916030.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtrade Products, Ltd. · MDA Elastomer, Silicone, For Scar Management
Cleared on Feb 14, 2002 as substantially equivalent to K002488 (Advanced Bio-Technologies, Inc., 2001) after a 69-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.
- Decided
- Feb 14, 2002
- Review
- 69 days
- Class
- Class I
- Product code
- MDA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002488 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002488 Kelo-Cote Topical GelAdvanced Bio-Technologies, Inc. · 2001
- This deviceK014036 Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp.…Medtrade Products, Ltd. · 2002
- Descendant · cites it directly · 1 of its ownK083718 Beau RX Scar Care GelBeau RX Solutions, LLC · 2009
- Descendant · 2 generations on · 0 of its ownK131672 Microcyn Scar Management HydrogelOculus Innovative Sciences · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002488 | Kelo-Cote Topical Gel | Advanced Bio-Technologies, Inc. | 2001 | — |
| 0 (this device) | K014036 | Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp. 2ND Skin… | Medtrade Products, Ltd. | 2002 | — |
| +1 | K083718 | Beau RX Scar Care Gel | Beau RX Solutions, LLC | 2009 | — |
| +2 | K131672 | Microcyn Scar Management Hydrogel | Oculus Innovative Sciences | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K002488 | Kelo-Cote Topical GelSummary page 1…ines. MedTrade Product’s Silicone Scar Gel is substantially equivalent in design, composition and function Kilo-cote Manufactured by Advanced Bio-Technologies 510(k) # K002488. A table of comparative features may be found below. Labelling for substantial equivalent product may be found on pages 16 to 19… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083718 | Beau RX Scar Care Gel | 2009 | 1 |
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?
How does its category compare?
All MDA devicesMDA Elastomer, Silicone, For Scar Management: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MDA
2in 2011
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
MedTrade Product's Silicone Scar Gel is intended for the management of:
Old and new hypertropic and keloid scarring on scars resulting from burns,
general surgical procedures and trauma wounds
Help Soften, Smooth and Flatten Scars
It is not indicated for use on:
Open or infected wounds, scabs or stitches
New wounds which have breached the dermis
Materials present in the product do not contra-indicate topical (skin/scar)
applications.
The components do not contain animal ingredients.
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/K014036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014036: Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp. 2ND Skin Silicone Scar Therapy Gel, Model 09916030..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014036
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026