510(k) · Cleared
ClearedMedline Tender Wet Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Apr 17, 2000 after a 329-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 17, 2000
- Review
- 329 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
Medline TenderWet™ is a multi-layer wound dressing pad whose central component is a super-absorbent polymer (SAP). This product maintains a moist wound environment that supports the healing process by encouraging autolytic debridement and allowing granulation to proceed under optimum conditions. It protects against dehydration, bacterial contamination, and absorbs exudate from the wound. It is indicated for use on dry, light and moderately exuding…
Read the full statement (129 words)
Medline TenderWet™ is a multi-layer wound dressing pad whose central component is a super-absorbent polymer (SAP). This product maintains a moist wound environment that supports the healing process by encouraging autolytic debridement and allowing granulation to proceed under optimum conditions. It protects against dehydration, bacterial contamination, and absorbs exudate from the wound. It is indicated for use on dry, light and moderately exuding partial and full thickness wounds such as: First and second degree burns, superficial injuries, lacerations, cuts, abrasions, incisions/surgical wounds, and skin tears. Medline TenderWet™ should be used under direction of a healith care professional for Stage I-1V Pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, and ulcers of mixed etiology. Medline TenderWet™ may be used to condition wound sites prior to skin transplants.
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/K991755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991755: Medline Tender Wet Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991755
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026