510(k) · Cleared
ClearedAdvanced Medical Solutions-Silicone Gel Scar Management Sheet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Solutions Group Plc · MDA Elastomer, Silicone, For Scar Management
Cleared on Jun 11, 1999 as substantially equivalent to K981902 (Spenco Medical Corp., 1998) after a 31-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jun 11, 1999
- Review
- 31 days
- Class
- Class I
- Product code
- MDA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981902 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK981902 Spenco Silicone Gel SheetSpenco Medical Corp. · 1998
- This deviceK991630 Advanced Medical Solutions-Silicone Gel Scar Management SheetAdvanced Medical Solutions Group Plc · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981902 | Spenco Silicone Gel Sheet | Spenco Medical Corp. | 1998 | — |
| 0 (this device) | K991630 | Advanced Medical Solutions-Silicone Gel Scar Management Sheet | Advanced Medical Solutions Group Plc | 1999 | — |
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 |
|---|---|---|---|
| * | K981902 | Spenco Silicone Gel SheetSummary page 2…other devices approved by the FDA under the device clagsificalion, Elaslomer, Silicuone [or scar management. Predictive devices include Spenco Silicone Gel Sheet 510(k) K981902, Spenco Medical Corp. LS % _,(C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service "R :'h Food and Drug… | 1998 |
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?
- Its one ancestor has no recall.
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?
Advanced Medical Solutions Silicone Gel Scar Management Sheet is intended for OTC use for the management of:
Old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.
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/K991630 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991630: Advanced Medical Solutions-Silicone Gel Scar Management Sheet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991630
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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