510(k) · Cleared
ClearedSkin 2 Forte Silicone Sheeting
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Hospital Technologies, Inc. · MDA Elastomer, Silicone, For Scar Management
Cleared on Aug 13, 1999 as substantially equivalent to K974380 (Rejuveness Pharamceuticals, Inc., 1998) after a 165-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Aug 13, 1999
- Review
- 165 days
- Class
- Class I
- Product code
- MDA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974380 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK974380 RejuvenessRejuveness Pharamceuticals, Inc. · 1998
- This deviceK990651 Skin 2 Forte Silicone SheetingUnited Hospital Technologies, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974380 | Rejuveness | Rejuveness Pharamceuticals, Inc. | 1998 | — |
| 0 (this device) | K990651 | Skin 2 Forte Silicone Sheeting | United Hospital Technologies, Inc. | 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 |
|---|---|---|---|
| * | K974380 | RejuvenessSummary page 1…stantial Equivalence The new product is substantially equivalent to the currently marketed ReJuveness product manufactured and marketed by RichMark International Corp. (K974380). The ReJuveness product is offered for sale as an “over the counter” product. Description Skin 2 forté Silicone Sheeting is a… | 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.
- 3 other devices also cite its predicate K974380.
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?
SKIN 2 forté Silicone Sheeting is indicated for the management of hypertrophic and keloid scars. Consistent use of SKIN 2 forté can reduce hypertrophic and keloid scars.
SKIN 2 forté may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic and keloid scars.
SKIN 2 forté may be used as soon as the wound is closed, dry and the sutures or staples have been removed.
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/K990651 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990651: Skin 2 Forte Silicone Sheeting.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990651
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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