510(k) · Cleared
ClearedRejuveness
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rejuveness Pharamceuticals, Inc. · MDA Elastomer, Silicone, For Scar Management
Cleared on Apr 3, 1998 after a 164-day review. The FDA summary names no predicate by number. 6 later devices descend from it.
- Decided
- Apr 3, 1998
- Review
- 164 days
- Class
- Class I
- Product code
- MDA
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK974380 RejuvenessRejuveness Pharamceuticals, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK982036 Silon Scar StripsBio Med Sciences, Inc. · 1998
- Descendant · 2 generations on · 1 of its ownK023136 Oleeva FabricBio Med Sciences, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK024160 Neosporin Scar SolutionWarner-Lambert Co. · 2003
- Descendant · cites it directly · 0 of its ownK991970 Scarease Sheets & Scarease GelPillar Surgical · 1999
- Descendant · cites it directly · 0 of its ownK990651 Skin 2 Forte Silicone SheetingUnited Hospital Technologies, Inc. · 1999
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K982036Silon Scar StripsBio Med Sciences, Inc. · 1998 · cites it directly2descendants
- K023136Oleeva FabricBio Med Sciences, Inc. · 2002 · 2 generations on1descendant
- K024160Neosporin Scar SolutionWarner-Lambert Co. · 2003 · 2 generations on0descendants
- K991970Scarease Sheets & Scarease GelPillar Surgical · 1999 · cites it directly0descendants
- K990651Skin 2 Forte Silicone SheetingUnited Hospital Technologies, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974380 | Rejuveness | Rejuveness Pharamceuticals, Inc. | 1998 | — |
| +1 | K982036 | Silon Scar Strips | Bio Med Sciences, Inc. | 1998 | — |
| +2 | K023136 | Oleeva Fabric | Bio Med Sciences, Inc. | 2002 | — |
| +2 | K024160 | Neosporin Scar Solution | Warner-Lambert Co. | 2003 | — |
| +1 | K991970 | Scarease Sheets & Scarease Gel | Pillar Surgical | 1999 | — |
| +1 | K990651 | Skin 2 Forte Silicone Sheeting | United Hospital Technologies, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (6)
4 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?
- Of its descendants, K982036 (Bio Med Sciences, Inc., 1998) has gone furthest, with 2 descendants 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?
MANAGEMENT OF HYPERTROPHIC AND KELOID SCARS
o ReJuveness™ is effective in the management of hypertrophic and keloid scars.
e Consistent use of ReJuveness ™ can reduce hypertrophic and keloid scarring.
PREVENTION OF HYPERTROPHIC AND KELOID SCARS
e ReJuveness may be useful as a prophylaxis on closed scars to aid in the prevention of hypertrophic and keloid scarring.
¢ Ifused following surgical procedures, ReJuveness™ may prevent hypertrophic and keloid scamming.
¢ Reluveness™ can be used as soon as the wound is closed, dry and the sutures have been removed.
RelJuveness™ may prevent scarnng disorders.
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/K974380 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974380: Rejuveness.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974380
Report an extraction error
Are you the manufacturer?
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