510(k) Report

510(k) · Cleared

Cleared

MPM Hydrogel Dressing (Non-Sterile)

K962160510(k) TraditionalCleared Jun 26, 199622-day reviewClass U

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

Mpm Medical., Inc. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Cleared on Jun 26, 1996 as substantially equivalent to K933495 (Marketing Professionals IN Medicine, Inc., 1994) and 3 other predicates after a 22-day review. Its family tree reaches back 1 generation to 1993.

Decided
Jun 26, 1996
Review
22 days
Class
Class U
Product code
MGQ
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K930560 (1993). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 2 other ancestors1994: 1 other ancestorK930560 · MPM Hydrogel Saturated Dressing · Mpm Medical., Inc. · 199319901992199419961998
Other ancestors, by generation 1 generation back: 3 other ancestors K930560 · MPM Hydrogel Saturated Dressing · Mpm Medical., Inc. · 19930
  1. Root · 1 generation backK930560 MPM Hydrogel Saturated DressingMpm Medical., Inc. · 1993
  2. This deviceK962160 MPM Hydrogel Dressing (Non-Sterile)Mpm Medical., Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K930560MPM Hydrogel Saturated DressingMpm Medical., Inc.1993—
0 (this device)K962160MPM Hydrogel Dressing (Non-Sterile)Mpm Medical., Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199520
FIG. 1 — Lineage of K962160, 1993–1996Source: 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), 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? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K933495MPM Gelpad (Hydrogel Saturated Sterile Gauze Pads)
Summary page 1
…Hydroge!™ Dressing (Non-Sterile) Common Name: Wound Dressing Classification Name: Hydrogel wound and burn dressing PREDICATE DEVICES 1. MPM GelPad (MPM Medical, Inc.); K933495 2. MPM Sterile Hydrogel Dressing in pre-filied syringes (MPM Medical, Inc); K950934 3. MPM Sterile Hydrogel Dressing in plastic…
Marketing Professionals IN Medicine, Inc.1994—
*K950934MPM Hydrogel Dressing
Summary page 1
…drogel wound and burn dressing PREDICATE DEVICES 1. MPM GelPad (MPM Medical, Inc.); K933495 2. MPM Sterile Hydrogel Dressing in pre-filied syringes (MPM Medical, Inc); K950934 3. MPM Sterile Hydrogel Dressing in plastic bottles and tubes (MPM Medical, Inc.); K952276 4. MPM Hydrogel Saturated Dressing (…
Richard Hamer Assoc., Inc.1995—
*K952276MPM Hydrogel Dressing
Summary page 1
…2. MPM Sterile Hydrogel Dressing in pre-filied syringes (MPM Medical, Inc); K950934 3. MPM Sterile Hydrogel Dressing in plastic bottles and tubes (MPM Medical, Inc.); K952276 4. MPM Hydrogel Saturated Dressing (MPM Medical, Inc}, K930560 DEVICE DESCRIPTION The MPM Hydrogel Dressing is a clear, viscou…
Mpm Medical., Inc.1995—
*K930560MPM Hydrogel Saturated Dressing
Summary page 1
…edical, Inc); K950934 3. MPM Sterile Hydrogel Dressing in plastic bottles and tubes (MPM Medical, Inc.); K952276 4. MPM Hydrogel Saturated Dressing (MPM Medical, Inc}, K930560 DEVICE DESCRIPTION The MPM Hydrogel Dressing is a clear, viscous, non-sterile, hydrogel intended for use in the local managemen…
Mpm Medical., Inc.1993—

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?

  • None of the 4 ancestors has a 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

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—

What is it indicated for?

Local management of skin wounds, including pressure ulcers, Stage I-IV, stasis ulcers, first and second degree burns.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K933495

2 other devices cite the same predicate.

  • K981150Solosite Gel Conformable DressingSmith & Nephew, Inc. · 1998
  • K962439Dermaplex Hydrogel Wound Dressing (2X2,4X4,4X8,6X10)Richard Hamer Assoc., Inc. · 1996

More from Mpm Medical., Inc.

9 FDA decisions under this applicant name. See the company

  • K060340Oramagic Plus Oral Wound RinseMpm Medical., Inc. · 2006
  • K024180Oramagicrx Oral Wound RinseMpm Medical., Inc. · 2003
  • K020540Regenecare Wound GelMpm Medical., Inc. · 2002
  • K992074MPM Regenecare Wound GelMpm Medical., Inc. · 1999
  • K952276MPM Hydrogel DressingMpm Medical., Inc. · 1995

Recent decisions in MGQ

The MGQ category page

  • K171879HylaGuard Moisturizing CreamFounders Science Group, LLC · 2017
  • K083024Hylatopic Emollient FoamCollegium Pharmaceutical Incorporated · 2009
  • K041342Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005
  • K041268Silversite or CalgitrolAdri · 2004
  • K040019SilversealNoble Fiber Technologies · 2004

https://510kreport.com/device/K962160 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962160: MPM Hydrogel Dressing (Non-Sterile).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962160

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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