510(k) Report

510(k) · Cleared

Cleared

Interdry Textile with Silver

K061615510(k) TraditionalCleared Dec 22, 2006196-day reviewClass I21 CFR 880.5300

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

Milliken Chemical · FRL Fiber, Medical, Absorbent

Cleared on Dec 22, 2006 after a 196-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided
Dec 22, 2006
Review
196 days
Class
Class I
Product code
FRL
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2013: 1 descendant cleared20052010201520202025
  1. This deviceK061615 Interdry Textile with SilverMilliken Chemical · 2006
  2. Descendant · cites it directly · 1 of its ownK110715 Interdry SilverMilliken Healthcare Products, LLC · 2011
  3. Descendant · cites it directly · 0 of its ownK121898 Stay Fresh Skin Fold Management TextileQuick-Med Technologies, Inc. · 2013

Most influential descendants

Showing 2 of 2 · See all
  • K110715Interdry SilverMilliken Healthcare Products, LLC · 2011 · cites it directly1descendant
  • K121898Stay Fresh Skin Fold Management TextileQuick-Med Technologies, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K061615Interdry Textile with SilverMilliken Chemical2006—
+1K110715Interdry SilverMilliken Healthcare Products, LLC2011—
+1K121898Stay Fresh Skin Fold Management TextileQuick-Med Technologies, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201310
FIG. 1 — Lineage of K061615, 2006–2013Source: 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), 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*—SurePress Absorbent Padding
Named without a submission number
—

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110715Interdry SilverMilliken Healthcare Products, LLC20111
K121898Stay Fresh Skin Fold Management TextileQuick-Med Technologies, Inc.20130

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, K110715 (Milliken Healthcare Products, LLC, 2011) has gone furthest, with 1 descendant of its own.

How does its category compare?

All FRL devices

FRL Fiber, Medical, Absorbent: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRL

1in 2013

2011: 12013: 1
2007high 1 (2011) · low 0 (2007)2026

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

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FRL

4in 2025

2007: 12008: 12009: 12010: 12012: 12013: 12014: 12015: 42016: 52017: 102018: 212019: 132020: 262021: 132022: 42023: 62024: 92025: 4
2007high 26 (2020) · low 0 (2011)2025

MAUDE reports naming product code FRL, 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—01
20090—11
20100—01
20111—00
20120—01
20131—01
20140—01
20150—04
20160—05
20170—010
20180—021
20190—013
20200—026
20210—013
20220—04
20230—06
20240—09
20250—04
20260—0—

What is it indicated for?

InterDry Textile with Silver is a skin protectant indicated for management of skin folds and other skin-to-skin contact areas. InterDry Textile with Silver reduces microbial colonization in the fabric.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K061615: Interdry Textile with Silver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061615

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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