510(k) · Cleared
ClearedKelo-Cote Topical Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Bio-Technologies, Inc. · MDA Elastomer, Silicone, For Scar Management
Cleared on Jan 5, 2001 after a 144-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jan 5, 2001
- Review
- 144 days
- Class
- Class I
- Product code
- MDA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK002488 Kelo-Cote Topical GelAdvanced Bio-Technologies, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK014036 Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp.…Medtrade Products, Ltd. · 2002
- Descendant · cites it directly · 1 of its ownK083718 Beau RX Scar Care GelBeau RX Solutions, LLC · 2009
- Descendant · cites it directly · 0 of its ownK131672 Microcyn Scar Management HydrogelOculus Innovative Sciences · 2013
- Descendant · cites it directly · 0 of its ownK053481 Kelo-Cote SprayAdvanced Bio-Technologies, Inc. · 2006
Most influential descendants
Showing 4 of 4 · See all- K014036Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp. 2ND Skin Silicone Scar…Medtrade Products, Ltd. · 2002 · cites it directly2descendants
- K083718Beau RX Scar Care GelBeau RX Solutions, LLC · 2009 · cites it directly1descendant
- K131672Microcyn Scar Management HydrogelOculus Innovative Sciences · 2013 · cites it directly0descendants
- K053481Kelo-Cote SprayAdvanced Bio-Technologies, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002488 | Kelo-Cote Topical Gel | Advanced Bio-Technologies, Inc. | 2001 | — |
| +1 | K014036 | Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp. 2ND Skin… | Medtrade Products, Ltd. | 2002 | — |
| +1 | K083718 | Beau RX Scar Care Gel | Beau RX Solutions, LLC | 2009 | — |
| +1 | K131672 | Microcyn Scar Management Hydrogel | Oculus Innovative Sciences | 2013 | — |
| +1 | K053481 | Kelo-Cote Spray | Advanced Bio-Technologies, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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, K014036 (Medtrade Products, Ltd., 2002) 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 | — |
https://510kreport.com/device/K002488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002488: Kelo-Cote Topical Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002488
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026