510(k) · Cleared
ClearedSilon Scar Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio Med Sciences, Inc. · MDA Elastomer, Silicone, For Scar Management
Cleared on Aug 6, 1998 as substantially equivalent to K932214 (Bio Med Sciences, Inc., 1994) and 1 other predicate after a 57-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Aug 6, 1998
- Review
- 57 days
- Class
- Class I
- Product code
- MDA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932214 (1994). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK932214 Silon Silicone Gel SheetBio Med Sciences, Inc. · 1994
- This deviceK982036 Silon Scar StripsBio Med Sciences, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK023136 Oleeva FabricBio Med Sciences, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK024160 Neosporin Scar SolutionWarner-Lambert Co. · 2003
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 | K932214 | Silon Silicone Gel Sheet | Bio Med Sciences, Inc. | 1994 | — |
| 0 (this device) | K982036 | Silon Scar Strips | Bio Med Sciences, Inc. | 1998 | — |
| +1 | K023136 | Oleeva Fabric | Bio Med Sciences, Inc. | 2002 | — |
| +1 | K024160 | Neosporin Scar Solution | Warner-Lambert Co. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 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? (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 | Decided |
|---|---|---|---|
| * | K932214 | Silon Silicone Gel SheetSummary page 1…in the prevention of hypertrophic scars and keloids. SUBSTANTIAL EQUIVALENCE The new product is substantially equivalent to the existing Silon-SES product (510(k) No. K932214), as well as Rejuveness (510(k) No. K974380) by Rich Mark International — which offers their product for sale “over-the-counter”.… | 1994 |
| * | K974380 | RejuvenessSummary page 1…keloids. SUBSTANTIAL EQUIVALENCE The new product is substantially equivalent to the existing Silon-SES product (510(k) No. K932214), as well as Rejuveness (510(k) No. K974380) by Rich Mark International — which offers their product for sale “over-the-counter”. BIOCOMPATIBILTY SUMMARY The Silon-SES mat… | 1998 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K023136 (Bio Med Sciences, Inc., 2002) has gone furthest, with 1 descendant of its own.
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?
Silon Scar Strips are indicated for the management of hypertrophic scars and keloids. Consistent use of Silon Scar Strips can reduce hypertrophic scaring and keloid formation resulting from surgical or traumatic injury of the skin.
Silon Scar Strips 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982036 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982036: Silon Scar Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982036
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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