510(k) · Cleared
ClearedOleeva Fabric
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 Oct 16, 2002 as substantially equivalent to K982036 (Bio Med Sciences, Inc., 1998) and 1 other predicate after a 26-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Oct 16, 2002
- Review
- 26 days
- Class
- Class I
- Product code
- MDA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K932214 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK932214 Silon Silicone Gel SheetBio Med Sciences, Inc. · 1994
- 1 generation backK982036 Silon Scar StripsBio Med Sciences, Inc. · 1998
- This deviceK023136 Oleeva FabricBio Med Sciences, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK024160 Neosporin Scar SolutionWarner-Lambert Co. · 2003
Most influential descendants
Showing 1 of 1 · See all- K024160Neosporin Scar SolutionWarner-Lambert Co. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932214 | Silon Silicone Gel Sheet | Bio Med Sciences, Inc. | 1994 | — |
| −1 | K982036 | Silon Scar Strips | Bio Med Sciences, Inc. | 1998 | — |
| 0 (this device) | 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 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K982036 | Silon Scar StripsSummary page 1…cars and keloids. SUBSTANTIAL EQUIVALENCE The new device is substantially equivalent to the existing Oleeva Fabric product (K982036), Oleeva Foam (K002109), as well as the other silicone sheeting products manufactured by Bio Med Sciences, Inc.… | 1998 |
| * | K002109 | Oleeva FoamSummary page 1…SUBSTANTIAL EQUIVALENCE The new device is substantially equivalent to the existing Oleeva Fabric product (K982036), Oleeva Foam (K002109), as well as the other silicone sheeting products manufactured by Bio Med Sciences, Inc. BIOCOMPATIBIL… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024160 | Neosporin Scar Solution | 2003 | 0 |
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?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 4.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K024160 (Warner-Lambert Co., 2003) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K982036.
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?
Oleeva Fabric is indicated for the management of hypertrophic scars and keloids. Consistent use of Oleeva Fabric can reduce hypertrophic scaring and keloid formation resulting from surgical or traumatic injury of the skin.
Oleeva Fabric 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 as stated in the FDA summary.
https://510kreport.com/device/K023136 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023136: Oleeva Fabric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023136
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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