510(k) · Cleared
Recalled · Class II · 2015Amerigel Ointment Saturated Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amerx Health Care Corp. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Aug 12, 1997 as substantially equivalent to K970133 (Amerx Health Care Corp., 1997) after an 81-day review. Its family tree reaches back 1 generation to 1997. It has been recalled 11 times.
- Decided
- Aug 12, 1997
- Review
- 81 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- 11
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970133 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK970133 Amerigel OintmentAmerx Health Care Corp. · 1997 · Recalled
- This deviceK971918 Amerigel Ointment Saturated Wound DressingAmerx Health Care Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970133 | Amerigel Ointment | Amerx Health Care Corp. | 1997 | 2 |
| 0 (this device) | K971918 | Amerigel Ointment Saturated Wound Dressing | Amerx Health Care Corp. | 1997 | — |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
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 | Decided |
|---|---|---|---|
| * | K970133 | Amerigel OintmentSummary page 3…KAYI918 May 15, 1997 Amerx Health Care Corporation 510(k) submission for a Saturated Non-Interactive Wound Dressing (Amerigel) Frud i ep Yo 510(k) Number (if known): _K970133 - April 14, 1997 for Amerigel™ Qintment Wound Dressing Device Name: AmerigelTM Qintment Saturated Wound Dressing lTM Amerigel™… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 25, 2015 | Class II | Z-1797-2015 | Labeling False and Misleading | Nonapproved labeling claims (Sterile) |
| Sep 26, 2014 | Class II | Z-0499-2015 | Mixed-up of materials/components | Formulation deviation |
| Sep 26, 2014 | Class II | Z-0497-2015 | Mixed-up of materials/components | Formulation deviation |
| Sep 26, 2014 | Class II | Z-0498-2015 | Mixed-up of materials/components | Formulation deviation |
| Sep 26, 2014 | Class II | Z-0500-2015 | Mixed-up of materials/components | Formulation deviation |
| Jul 11, 2014 | Class II | Z-2639-2014 | Labeling design | Not approved labeling claims (antimicrobial and autolytic debridement) |
| Jul 11, 2014 | Class II | Z-2641-2014 | Labeling design | Not approved labeling claims (antimicrobial and autolytic debridement) |
| Jul 11, 2014 | Class II | Z-2640-2014 | Labeling design | Not approved labeling claims (antimicrobial and autolytic debridement) |
| Jul 11, 2014 | Class II | Z-2638-2014 | Labeling design | Not approved labeling claims (antimicrobial and autolytic debridement) |
| Mar 21, 2014 | Class II | Z-1992-2014 | Process control | Product may not have been manufactured pursuant to a validated process protocol and CGMP. |
| Mar 21, 2014 | Class II | Z-1993-2014 | Process control | Product may not have been manufactured pursuant to a validated process protocol and CGMP. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All MGQ devicesMGQ 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
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGQ
5in 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 management of open wounds.
For use as a wound dressing to manage pressure ulcers stages I-IV, stasis ulcers, diabetic skin ulcers, skin irritation, cuts, abrasions and skin irritations associated with periostomal care.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971918 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971918: Amerigel Ointment Saturated Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971918
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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