510(k) Report

510(k) · Cleared

Cleared

MPM Gelpad (Hydrogel Saturated Sterile Gauze Pads)

K933495510(k) TraditionalCleared Jan 12, 1994177-day reviewClass U

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

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.

Descendants, by year cleared 1996: 2 descendants cleared1998: 1 descendant cleared2012: 1 descendant cleared1990200020102020
  1. This deviceK933495 MPM Gelpad (Hydrogel Saturated Sterile Gauze Pads)Marketing Professionals IN Medicine, Inc. · 1994
  2. Descendant · cites it directly · 1 of its ownK981150 Solosite Gel Conformable DressingSmith & Nephew, Inc. · 1998
  3. Descendant · 2 generations on · 0 of its ownK122297 Enluxtra Humifiber Wound DressingBasf Venture Capital America, Inc. · 2012
  4. Descendant · cites it directly · 0 of its ownK962439 Dermaplex Hydrogel Wound Dressing (2X2,4X4,4X8,6X10)Richard Hamer Assoc., Inc. · 1996
  5. 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933495MPM Gelpad (Hydrogel Saturated Sterile Gauze Pads)Marketing Professionals IN Medicine, Inc.1994—
+1K981150Solosite Gel Conformable DressingSmith & Nephew, Inc.1998—
+2K122297Enluxtra Humifiber Wound DressingBasf Venture Capital America, Inc.2012—
+1K962439Dermaplex Hydrogel Wound Dressing (2X2,4X4,4X8,6X10)Richard Hamer Assoc., Inc.1996—
+1K962160MPM Hydrogel Dressing (Non-Sterile)Mpm Medical., Inc.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199810
201210
FIG. 1 — Lineage of K933495, 1994–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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  • Recall history across each candidate’s familyin the report
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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.

NumberDeviceApplicantDecidedDescendants
K981150Solosite Gel Conformable DressingSmith & Nephew, Inc.19981
K962439Dermaplex Hydrogel Wound Dressing (2X2,4X4,4X8,6X10)Richard Hamer Assoc., Inc.19960
K962160MPM Hydrogel Dressing (Non-Sterile)Mpm Medical., Inc.19960

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 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

2009: 12017: 1
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

2014: 4
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

2007: 12009: 22010: 32011: 52012: 12013: 42014: 102015: 32016: 42017: 62018: 22019: 22020: 62021: 12023: 62024: 112025: 5
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—00
20091—02
20100—03
20110—05
20120—01
20130—04
20140—410
20150—03
20160—04
20171—06
20180—02
20190—02
20200—06
20210—01
20220—00
20230—06
20240—011
20250—05
20260—0—
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