510(k) · Cleared
ClearedDermaplex Hydrogel Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxxim Medical · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Sep 12, 1996 as substantially equivalent to K950412 (Kendall Healthcare Products Co. Div.Of Tyco Health, 1995) after a 77-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 12, 1996
- Review
- 77 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950412 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK950412 Curagel Hydrogel Wound DressingKendall Healthcare Products Co. Div.Of Tyco Health · 1995
- This deviceK962513 Dermaplex Hydrogel Wound DressingMaxxim Medical · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950412 | Curagel Hydrogel Wound Dressing | Kendall Healthcare Products Co. Div.Of Tyco Health | 1995 | — |
| 0 (this device) | K962513 | Dermaplex Hydrogel Wound Dressing | Maxxim Medical | 1996 | — |
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 |
|---|---|---|---|
| * | K950412 | Curagel Hydrogel Wound DressingSummary page 1…ng Common Name: Wound Dressing Classification Name: Hydrogel wound and burn dressing PREDICATE DEVICE Curagel Hydrogel Wound Dressing; Kendall Healthcare Products Co.; K950412 DEVICE DESCRIPTION The Dermaplex Hydrogel Wound Dressing is a solid hydrogel dressing covered with a polyester liner which is r… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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?
For the local management of pressure ulcers, stasis ulcers, 1st and 2nd degree burns, and full and partial thickness wounds.
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/K962513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962513: Dermaplex Hydrogel Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962513
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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