510(k) · Cleared

Cleared

Dermaplex Hydrogel Wound Dressing (2X2,4X4,4X8,6X10)

K962439510(k) TraditionalCleared Sep 3, 199671-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Richard Hamer Assoc., Inc. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Cleared on Sep 3, 1996 as substantially equivalent to K933495 (Marketing Professionals IN Medicine, Inc., 1994) after a 71-day review. Its family tree reaches back 1 generation to 1994.

Decided: Sep 3, 1996
Review: 71 days
Class: Class U
Product code: MGQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K933495 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK933495 MPM Gelpad (Hydrogel Saturated Sterile Gauze Pads)Marketing Professionals IN Medicine, Inc. · 1994
This deviceK962439 Dermaplex Hydrogel Wound Dressing (2X2,4X4,4X8,6X10)Richard Hamer Assoc., Inc. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K933495	MPM Gelpad (Hydrogel Saturated Sterile Gauze Pads)	Marketing Professionals IN Medicine, Inc.	1994	—
0 (this device)	K962439	Dermaplex Hydrogel Wound Dressing (2X2,4X4,4X8,6X10)	Richard Hamer Assoc., Inc.	1996	—

FIG. 1 — Lineage of K962439, 1994–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K933495	MPM Gelpad (Hydrogel Saturated Sterile Gauze Pads) Summary page 1 …ng Common Name: Wound Dressing Classification Name: Hydrogel wound and burn dressing PREDICATE DEVICE MPM GelPad (Hydrogel Saturated Sterile Gauze); MPM Medical, Inc.; K933495. DEVICE DESCRIPTION The Dermaplex Hydrogel Wound Dressing consists of a 12-ply cotton gauze pad dressing impregnated with a cle…	Marketing Professionals IN Medicine, Inc.	1994	—

Also cleared against K933495: 2 other devices →

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.
2 other devices also cite its predicate K933495.

How does its category compare?

All MGQ devices

MGQ 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

2007high 1 (2009) · low 0 (2007)2026

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

2007high 4 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MGQ

5in 2025

2007high 11 (2024) · low 0 (2008)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/K962439 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962439: Dermaplex Hydrogel Wound Dressing (2X2,4X4,4X8,6X10).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962439

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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