510(k) · Cleared
ClearedMPM Hydrogel Dressing
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 Jun 30, 1995 after a 46-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it.
- Decided
- Jun 30, 1995
- Review
- 46 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK952276 MPM Hydrogel DressingMpm Medical., Inc. · 1995
- Descendant · cites it directly · 8 of its ownK992074 MPM Regenecare Wound GelMpm Medical., Inc. · 1999
- Descendant · 2 generations on · 7 of its ownK020540 Regenecare Wound GelMpm Medical., Inc. · 2002
- Descendant · 3 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 · 4 generations on · 2 of its ownK150792 Next Science Wound GelNext Science, LLC · 2015
- Descendant · 5 generations on · 1 of its ownK163188 Next Science Wound Gel (Rx)Next Science, LLC · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K992074MPM Regenecare Wound GelMpm Medical., Inc. · 1999 · cites it directly8descendants
- K020540Regenecare Wound GelMpm Medical., Inc. · 2002 · 2 generations on7descendants
- K092086Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G Tube), Model…Amerx Health Care Corp. · 2009 · 3 generations on6descendants
- K150792Next Science Wound GelNext Science, LLC · 2015 · 4 generations on2descendants
- K163188Next Science Wound Gel (Rx)Next Science, LLC · 2017 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952276 | MPM Hydrogel Dressing | Mpm Medical., Inc. | 1995 | — |
| +1 | K992074 | MPM Regenecare Wound Gel | Mpm Medical., Inc. | 1999 | — |
| +2 | K020540 | Regenecare Wound Gel | Mpm Medical., Inc. | 2002 | — |
| +3 | K092086 | Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G… | Amerx Health Care Corp. | 2009 | — |
| +4 | K150792 | Next Science Wound Gel | Next Science, LLC | 2015 | — |
| +5 | K163188 | Next Science Wound Gel (Rx) | Next Science, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 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), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (10)
2 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, K992074 (Mpm Medical., Inc., 1999) has gone furthest, with 8 descendants of its own.
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 | — |
https://510kreport.com/device/K952276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952276: MPM Hydrogel Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952276
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026