510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Amerigel Ointment

K970133510(k) TraditionalCleared Apr 14, 199789-day reviewClass URecalls 2

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

Amerx Health Care Corp. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Cleared on Apr 14, 1997 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.

Decided
Apr 14, 1997
Review
89 days
Class
Class U
Product code
MGQ
Recalls
2
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1995200020052010201520202025
  1. This deviceK970133 Amerigel OintmentAmerx Health Care Corp. · 1997
  2. Descendant · cites it directly · 0 of its ownK971918 Amerigel Ointment Saturated Wound DressingAmerx Health Care Corp. · 1997 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K971918Amerigel Ointment Saturated Wound DressingAmerx Health Care Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K970133Amerigel OintmentAmerx Health Care Corp.1997—
+1K971918Amerigel Ointment Saturated Wound DressingAmerx Health Care Corp.199711

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K970133, 1997–1997Source: 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K971918Amerigel Ointment Saturated Wound DressingAmerx Health Care Corp.19970

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 20, 2016Class IIZ-2249-2016OtherProduct did not meet specifications for Zinc Acetate (OOS).
Feb 25, 2015Class IIZ-1797-2015Labeling False and MisleadingNonapproved labeling claims (Sterile)

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K971918 (Amerx Health Care Corp., 1997) has gone furthest, with 0 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 Amerx Health Care Corp.

3 FDA decisions under this applicant name. See the company

  • K092086Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G Tube), Model A2026; 3 OZ (90G…Amerx Health Care Corp. · 2009
  • K971918Amerigel Ointment Saturated Wound DressingAmerx Health Care Corp. · 199711 recalls

Recent decisions in MGQ

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/K970133 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970133: Amerigel Ointment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970133

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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