510(k) Report

510(k) · Cleared

Cleared

Ambu Gel, Hydrogel Burn Dressing

K010583510(k) TraditionalCleared May 25, 200187-day reviewClass U

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

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

Cleared on May 25, 2001 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 98 later devices descend from it.

Decided
May 25, 2001
Review
87 days
Class
Class U
Product code
MGQ
Recalls
None
Predicates
0

98 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2007: 2 descendants cleared2006: 1 descendant cleared2009: 6 descendants cleared2008: 3 descendants cleared2016: 5 descendants cleared2011: 2 descendants cleared2014: 6 descendants cleared2010: 4 descendants cleared2015: 6 descendants cleared2012: 2 descendants cleared2017: 8 descendants cleared2013: 3 descendants cleared2019: 3 descendants cleared2018: 5 descendants cleared2020: 3 descendants cleared2022: 6 descendants cleared2025: 5 descendants cleared2026: 13 descendants cleared2024: 7 descendants cleared2023: 6 descendants cleared2021: 1 descendant cleared200020052010201520202025
  1. This deviceK010583 Ambu Gel, Hydrogel Burn DressingAmbu, Inc. · 2001
  2. Descendant · cites it directly · 97 of its ownK040019 SilversealNoble Fiber Technologies · 2004
  3. Descendant · 2 generations on · 73 of its ownK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
  4. Descendant · 3 generations on · 66 of its ownK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
  5. Descendant · 4 generations on · 37 of its ownK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
  6. Descendant · 4 generations on · 31 of its ownK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010

Showing 5 of 98 descendants. See all descendants

Descendants cleared per year

2004: 12006: 12007: 22008: 32009: 62010: 42011: 22012: 22013: 32014: 62015: 62016: 52017: 82018: 52019: 32020: 32021: 12022: 62023: 62024: 72025: 52026: 13
2004high 13 (2026) · low 0 (2005)2026

Most influential descendants

Showing 5 of 98 · See all
  • K040019SilversealNoble Fiber Technologies · 2004 · cites it directly97descendants
  • K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007 · 2 generations on73descendants
  • K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008 · 3 generations on66descendants
  • K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · 4 generations on37descendants
  • K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010 · 4 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010583Ambu Gel, Hydrogel Burn DressingAmbu, Inc.2001—
+1K040019SilversealNoble Fiber Technologies2004—
+2K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC2007—
+3K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and…Anacapa Technologies, Inc.2008—
+4K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc.20093
+4K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
200720
200830
200960
201040
201120
201220
201330
201460
201560
201650
201780
201850
201930
202030
202110
202260
202360
202470
202550
2026130
FIG. 1 — Lineage of K010583, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (98)

See all 98

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040019SilversealNoble Fiber Technologies200497

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, K040019 (Noble Fiber Technologies, 2004) has gone furthest, with 97 descendants 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—

More from Ambu, Inc.

33 FDA decisions under this applicant name. See the company

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  • K042843Ambu Spur II Infant and Pediatric Single Patient Use ResuscitatorsAmbu, Inc. · 20041 recall
  • K041734Ambu Disposable Ecg ElectrodeAmbu, Inc. · 2004
  • K040991Ambu Disposable Pressure ManometerAmbu, Inc. · 2004

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The MGQ category page

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  • 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/K010583 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010583: Ambu Gel, Hydrogel Burn Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010583

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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