510(k) · Cleared
ClearedStay Fresh Skin Fold Management Textile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quick-Med Technologies, Inc. · FRL Fiber, Medical, Absorbent
Cleared on May 24, 2013 as substantially equivalent to K110715 (Milliken Healthcare Products, LLC, 2011) and 1 other predicate after a 329-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- May 24, 2013
- Review
- 329 days
- Class
- Class I
- Product code
- FRL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K061615 (2006). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRL? 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? (3)
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 |
|---|---|---|---|
| * | K110715 | Interdry Silver | 2011 |
| * | K061615 | Interdry Textile with SilverSummary page 1…fiber Classification Regulation: 21 CFR 880.5300 Product Code: FRL 3. PREDICATE DEVICES * Milliken Interdry Textile with Silver subject of KI 10715, K061615 a ConvaTec SurePress® Absorbent Padding which is listed with the FDA by Convatec 4. DEVICE DESCRIPTION Ski)) Fresh Skin Fold… | 2006 |
| * | — | ConvaTec SurePress® Absorbent Padding Named without a submission number |
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.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All FRL devicesFRL Fiber, Medical, Absorbent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FRL
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FRL
Too few FRL 510(k)s in any year since 2007 to give a median.
Recalls per year · FRL
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRL
4in 2025
MAUDE reports naming product code FRL, 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 | 1 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 21 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 26 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stay Fresh Skin Fold Management Textile is a skin protectant intended to be used between
skin folds and in other skin-to-skin contact areas to provide moisture management and reduce
friction. The Stay Fresh Skin Fold Management Textile contains hydrogen peroxide, which
reduces bacterial populations in the fabric.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121898 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121898: Stay Fresh Skin Fold Management Textile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121898
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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