510(k) · Cleared
ClearedMPM Regenecare Wound Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mpm Medical., Inc. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Dec 23, 1999 as substantially equivalent to K952276 (Mpm Medical., Inc., 1995) after a 188-day review. Its family tree reaches back 1 generation to 1995. 8 later devices descend from it.
- Decided
- Dec 23, 1999
- Review
- 188 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952276 (1995). 8 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK952276 MPM Hydrogel DressingMpm Medical., Inc. · 1995
- This deviceK992074 MPM Regenecare Wound GelMpm Medical., Inc. · 1999
- Descendant · cites it directly · 7 of its ownK020540 Regenecare Wound GelMpm Medical., Inc. · 2002
- Descendant · 2 generations on · 6 of its ownK092086 Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ.…Amerx Health Care Corp. · 2009
- Descendant · 3 generations on · 2 of its ownK150792 Next Science Wound GelNext Science, LLC · 2015
- Descendant · 4 generations on · 1 of its ownK163188 Next Science Wound Gel (Rx)Next Science, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK254191 IWD-Gel™InnovaCorium, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K020540Regenecare Wound GelMpm Medical., Inc. · 2002 · cites it directly7descendants
- K092086Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G Tube), Model…Amerx Health Care Corp. · 2009 · 2 generations on6descendants
- K150792Next Science Wound GelNext Science, LLC · 2015 · 3 generations on2descendants
- K163188Next Science Wound Gel (Rx)Next Science, LLC · 2017 · 4 generations on1descendant
- K254191IWD-Gel™InnovaCorium, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952276 | MPM Hydrogel Dressing | Mpm Medical., Inc. | 1995 | — |
| 0 (this device) | K992074 | MPM Regenecare Wound Gel | Mpm Medical., Inc. | 1999 | — |
| +1 | K020540 | Regenecare Wound Gel | Mpm Medical., Inc. | 2002 | — |
| +2 | K092086 | Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G… | Amerx Health Care Corp. | 2009 | — |
| +3 | K150792 | Next Science Wound Gel | Next Science, LLC | 2015 | — |
| +4 | K163188 | Next Science Wound Gel (Rx) | Next Science, LLC | 2017 | — |
| +3 | K254191 | IWD-Gel™ | InnovaCorium, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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 MGQ? 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 |
|---|---|---|---|
| * | K952276 | MPM Hydrogel DressingSummary page 1…Regenecare™ Wound Gel Common Name: Wound Dressing Classification Name: Hydrogel wound and burn dressing ill. PREDICATE DEVICE MPM Hydrogel™ Dressing (MPM Medical, Inc.; K952276) IV. DEVICE DESCRIPTION MPM Regenecare™ Wound Gel is a viscous hydrogel wound dressing intended for use in the local management… | 1995 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020540 | Regenecare Wound Gel | 2002 | 7 |
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?
How does its category compare?
All MGQ devicesMGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGQ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MGQ
Too few MGQ 510(k)s in any year since 2007 to give a median.
Recalls per year · MGQ
4in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGQ
5in 2025
MAUDE reports naming product code MGQ, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 4 | 10 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 5 |
| 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992074 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992074: MPM Regenecare Wound Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992074
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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