510(k) Report

510(k) · Cleared

Cleared

Interdry Silver

K110715510(k) TraditionalCleared Nov 4, 2011234-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 Healthcare Products, LLC · FRL Fiber, Medical, Absorbent

Cleared on Nov 4, 2011 as substantially equivalent to K061615 (Milliken Chemical, 2006) after a 234-day review. Its family tree reaches back 1 generation to 2006. 1 later device descends from it.

Decided
Nov 4, 2011
Review
234 days
Class
Class I
Product code
FRL
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K061615 (2006). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2013: 1 descendant clearedK061615 · Interdry Textile with Silver · Milliken Chemical · 200620052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K061615 · Interdry Textile with Silver · Milliken Chemical · 20060
  1. Root · 1 generation backK061615 Interdry Textile with SilverMilliken Chemical · 2006
  2. This deviceK110715 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 1 of 1 · See all
  • 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
−1K061615Interdry Textile with SilverMilliken Chemical2006—
0 (this device)K110715Interdry SilverMilliken Healthcare Products, LLC2011—
+1K121898Stay Fresh Skin Fold Management TextileQuick-Med Technologies, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K110715, 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? (2)

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
*K061615Interdry Textile with Silver
Summary page 1
…ber, Medical, Absorbent (21 CFR 880.5300, Product Code FRL) 3. PREDICATE DEVICE * LnterDry Textile with Silver (K06 1615, Milliken Healthcare Products, LLC) * SurePress Absorbent Padding (21 CFR 880.5300, Convatec, Inc.) 4. DEVICE D…
Milliken Chemical2006—
*—SurePress Absorbent Padding
Named without a submission number
—

Also cleared against K061615: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
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?

  • Its one ancestor has no recall.
  • Of its descendants, K121898 (Quick-Med Technologies, Inc., 2013) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K061615.

How does its category compare?

All FRL devices

FRL Fiber, Medical, Absorbent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

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

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K110715: Interdry Silver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110715

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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