510(k) · Cleared
ClearedAmerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G Tube), Model A2026; 3 OZ (90G Tube),Model A2027
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amerx Health Care Corp. · SEJ Wound Dressings Containing Topical Analgesics
Cleared on Jul 30, 2009 as substantially equivalent to K020540 (Mpm Medical., Inc., 2002) after a 21-day review. Its family tree reaches back 3 generations to 1995. 6 later devices descend from it.
- Decided
- Jul 30, 2009
- Review
- 21 days
- Class
- Class U
- Product code
- SEJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K952276 (1995). 6 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK952276 MPM Hydrogel DressingMpm Medical., Inc. · 1995
- 2 generations backK992074 MPM Regenecare Wound GelMpm Medical., Inc. · 1999
- 1 generation backK020540 Regenecare Wound GelMpm Medical., Inc. · 2002
- This deviceK092086 Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ.…Amerx Health Care Corp. · 2009
- Descendant · cites it directly · 2 of its ownK150792 Next Science Wound GelNext Science, LLC · 2015
- Descendant · 2 generations on · 1 of its ownK163188 Next Science Wound Gel (Rx)Next Science, LLC · 2017
- Descendant · cites it directly · 0 of its ownK254191 IWD-Gel™InnovaCorium, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK252028 LUOFUCON® Antimicrobial Wound GelHuizhou Foryou Medical Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK211943 Microlyte Ag/LidocaineImbed Biosciences · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K150792Next Science Wound GelNext Science, LLC · 2015 · cites it directly2descendants
- K163188Next Science Wound Gel (Rx)Next Science, LLC · 2017 · 2 generations on1descendant
- K254191IWD-Gel™InnovaCorium, Inc. · 2026 · cites it directly0descendants
- K252028LUOFUCON® Antimicrobial Wound GelHuizhou Foryou Medical Co., Ltd. · 2026 · 3 generations on0descendants
- K211943Microlyte Ag/LidocaineImbed Biosciences · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952276 | MPM Hydrogel Dressing | Mpm Medical., Inc. | 1995 | — |
| −2 | K992074 | MPM Regenecare Wound Gel | Mpm Medical., Inc. | 1999 | — |
| −1 | K020540 | Regenecare Wound Gel | Mpm Medical., Inc. | 2002 | — |
| 0 (this device) | K092086 | Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G… | Amerx Health Care Corp. | 2009 | — |
| +1 | K150792 | Next Science Wound Gel | Next Science, LLC | 2015 | — |
| +2 | K163188 | Next Science Wound Gel (Rx) | Next Science, LLC | 2017 | — |
| +1 | K254191 | IWD-Gel™ | InnovaCorium, Inc. | 2026 | — |
| +3 | K252028 | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | 2026 | — |
| +1 | K211943 | Microlyte Ag/Lidocaine | Imbed Biosciences | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020540 | Regenecare Wound GelSummary page 1…burn, hydrogel w/drug and/or biologic Product Code: MGQ Regulatory Class: Unclassified Predicate Device #1: Trade/Device Name: RegenecareO Wound Gel (510(k) #K020540) Regulation Name: Hydrogel Wound Dressing Product Code: MGQ Regulatory Class: Unclassified Predicate Device #2: Tr… | 2002 |
| Kept off the family tree | K002136 | AmeriGel Wound Dressing Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…rogel Wound Dressing Product Code: MGQ Regulatory Class: Unclassified Predicate Device #2: Trade/Device Name: AmeriGelO Wound Dressing (510(k) #K002136) Classification Regulation Name: Hydrogel Wound Dressing (21 CFR 878.4022) Regulatory Class: Class I, exempt Pr… |
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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K150792 (Next Science, LLC, 2015) has gone furthest, with 2 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. 2009, this device’s year, is highlighted.
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?
Stage I - IV Pressure ulcers
Venous stasis ulcers.
Ulcerations caused by mixed vascular etiologies
Diabetic skin ulcers
First and second degree burns
Post-surgical incisions
Cuts and abrasions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092086 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092086: Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G Tube), Model A2026; 3 OZ (90G Tube),Model A2027.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092086
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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