510(k) · Cleared
ClearedMPM Gelpad (Hydrogel Saturated Sterile Gauze Pads)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marketing Professionals IN Medicine, Inc. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Jan 12, 1994 after a 177-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jan 12, 1994
- Review
- 177 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK933495 MPM Gelpad (Hydrogel Saturated Sterile Gauze Pads)Marketing Professionals IN Medicine, Inc. · 1994
- Descendant · cites it directly · 1 of its ownK981150 Solosite Gel Conformable DressingSmith & Nephew, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK122297 Enluxtra Humifiber Wound DressingBasf Venture Capital America, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK962439 Dermaplex Hydrogel Wound Dressing (2X2,4X4,4X8,6X10)Richard Hamer Assoc., Inc. · 1996
- Descendant · cites it directly · 0 of its ownK962160 MPM Hydrogel Dressing (Non-Sterile)Mpm Medical., Inc. · 1996
Most influential descendants
Showing 4 of 4 · See all- K981150Solosite Gel Conformable DressingSmith & Nephew, Inc. · 1998 · cites it directly1descendant
- K122297Enluxtra Humifiber Wound DressingBasf Venture Capital America, Inc. · 2012 · 2 generations on0descendants
- K962439Dermaplex Hydrogel Wound Dressing (2X2,4X4,4X8,6X10)Richard Hamer Assoc., Inc. · 1996 · cites it directly0descendants
- K962160MPM Hydrogel Dressing (Non-Sterile)Mpm Medical., Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933495 | MPM Gelpad (Hydrogel Saturated Sterile Gauze Pads) | Marketing Professionals IN Medicine, Inc. | 1994 | — |
| +1 | K981150 | Solosite Gel Conformable Dressing | Smith & Nephew, Inc. | 1998 | — |
| +2 | K122297 | Enluxtra Humifiber Wound Dressing | Basf Venture Capital America, Inc. | 2012 | — |
| +1 | K962439 | Dermaplex Hydrogel Wound Dressing (2X2,4X4,4X8,6X10) | Richard Hamer Assoc., Inc. | 1996 | — |
| +1 | K962160 | MPM Hydrogel Dressing (Non-Sterile) | Mpm Medical., Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2012 | 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 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? (4)
3 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, K981150 (Smith & Nephew, Inc., 1998) has gone furthest, with 1 descendant 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/K933495 · printed Nov 4, 2026
Cite this page
510(k) Report. “K933495: MPM Gelpad (Hydrogel Saturated Sterile Gauze Pads).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K933495
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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