510(k) · Cleared
ClearedRegenecare Wound Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mpm Medical., Inc. · SEJ Wound Dressings Containing Topical Analgesics
Cleared on Nov 1, 2002 as substantially equivalent to K992074 (Mpm Medical., Inc., 1999) after a 255-day review. Its family tree reaches back 2 generations to 1995. 7 later devices descend from it.
- Decided
- Nov 1, 2002
- Review
- 255 days
- Class
- Class U
- Product code
- SEJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952276 (1995). 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK952276 MPM Hydrogel DressingMpm Medical., Inc. · 1995
- 1 generation backK992074 MPM Regenecare Wound GelMpm Medical., Inc. · 1999
- This deviceK020540 Regenecare Wound GelMpm Medical., Inc. · 2002
- Descendant · cites it directly · 6 of its ownK092086 Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ.…Amerx Health Care Corp. · 2009
- Descendant · 2 generations on · 2 of its ownK150792 Next Science Wound GelNext Science, LLC · 2015
- Descendant · 3 generations on · 1 of its ownK163188 Next Science Wound Gel (Rx)Next Science, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK254191 IWD-Gel™InnovaCorium, Inc. · 2026
- Descendant · 4 generations on · 0 of its ownK252028 LUOFUCON® Antimicrobial Wound GelHuizhou Foryou Medical Co., Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K092086Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G Tube), Model…Amerx Health Care Corp. · 2009 · cites it directly6descendants
- K150792Next Science Wound GelNext Science, LLC · 2015 · 2 generations on2descendants
- K163188Next Science Wound Gel (Rx)Next Science, LLC · 2017 · 3 generations on1descendant
- K254191IWD-Gel™InnovaCorium, Inc. · 2026 · 2 generations on0descendants
- K252028LUOFUCON® Antimicrobial Wound GelHuizhou Foryou Medical Co., Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952276 | MPM Hydrogel Dressing | Mpm Medical., Inc. | 1995 | — |
| −1 | K992074 | MPM Regenecare Wound Gel | Mpm Medical., Inc. | 1999 | — |
| 0 (this device) | K020540 | Regenecare Wound Gel | Mpm Medical., Inc. | 2002 | — |
| +1 | K092086 | Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G… | Amerx Health Care Corp. | 2009 | — |
| +2 | K150792 | Next Science Wound Gel | Next Science, LLC | 2015 | — |
| +3 | K163188 | Next Science Wound Gel (Rx) | Next Science, LLC | 2017 | — |
| +2 | K254191 | IWD-Gel™ | InnovaCorium, Inc. | 2026 | — |
| +4 | K252028 | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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 SEJ? 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 |
|---|---|---|---|
| * | K992074 | MPM Regenecare Wound GelSummary page 1…Common Name: Medicated Wound Gel Classification Name: Medicated Hydrogel Wound and Burn Dressing 111. PREDICATE DEVICE MPM Regenecare'" Wound Gel; K992074 (MPM Medical, Inc.) IV. DEVICE DESCRIPTION Regenecare'" Wound Gel is a viscous hydrogel wound dressing containing 2 % w… | 1999 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092086 | Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G Tube), Model… | 2009 | 6 |
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 7 years and passes through 1 company; a new generation was cleared every 4.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K092086 (Amerx Health Care Corp., 2009) has gone furthest, with 6 descendants of its own.
How does its category compare?
All SEJ devicesSEJ Wound Dressings Containing Topical Analgesics: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · SEJ
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · SEJ
Too few SEJ 510(k)s in any year since 2007 to give a median.
Recalls per year · SEJ
No recall names SEJ since 2007.
Adverse event reports per year · SEJ
No MAUDE report names SEJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020540 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020540: Regenecare Wound Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020540
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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