510(k) · Cleared
ClearedEutra Gel for Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Swiss American Products, Inc. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Jul 18, 1994 after a 434-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jul 18, 1994
- Review
- 434 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK932291 Eutra Gel for Wound DressingSwiss American Products, Inc. · 1994
- Descendant · cites it directly · 1 of its ownK073019 Silvermed Antimicrobial Silver HydrogelArgentis Biomedical Incorporated · 2008
- Descendant · 2 generations on · 0 of its ownK132891 Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp. · 2014
- Descendant · cites it directly · 0 of its ownK990440 Gentell Hydrogel Spray Gel, Appligard SqueezeGentell · 1999
Most influential descendants
Showing 3 of 3 · See all- K073019Silvermed Antimicrobial Silver HydrogelArgentis Biomedical Incorporated · 2008 · cites it directly1descendant
- K132891Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp. · 2014 · 2 generations on0descendants
- K990440Gentell Hydrogel Spray Gel, Appligard SqueezeGentell · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K932291 | Eutra Gel for Wound Dressing | Swiss American Products, Inc. | 1994 | — |
| +1 | K073019 | Silvermed Antimicrobial Silver Hydrogel | Argentis Biomedical Incorporated | 2008 | — |
| +2 | K132891 | Hydrolyzed Collagen/AG Wound Gel with Silver | The Hymed Group Corp. | 2014 | — |
| +1 | K990440 | Gentell Hydrogel Spray Gel, Appligard Squeeze | Gentell | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
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
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? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K073019 (Argentis Biomedical Incorporated, 2008) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K932291 · printed Nov 4, 2026
Cite this page
510(k) Report. “K932291: Eutra Gel for 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/K932291
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026