510(k) Report

510(k) · Cleared

Cleared

Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM) Travel Stockings; Futuro (TM) Travel Pantyhose

K123085510(k) TraditionalCleared Dec 20, 201280-day reviewClass II21 CFR 880.5780

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

3M Company · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Cleared on Dec 20, 2012 as substantially equivalent to K032325 (Bsn-Jobst, Inc., 2003) and 1 other predicate after an 80-day review. Its family tree reaches back 5 generations to 1995.

Decided
Dec 20, 2012
Review
80 days
Class
Class II
Product code
DWL
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K955138 (1995). 7 ancestors in all, the oldest K830696 (1983). No later device cites it as a predicate yet.

  1. Root · 5 generations backK955138 Anti-EM/GP StockingsJobst Institute, Inc. · 1995
  2. 4 generations backK032325 Jobst Travel SocksBsn-Jobst, Inc. · 2003
  3. 3 generations backK040353 Flight SockSsl Americas, Inc. · 2004
  4. 2 generations backK091141 Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's…Knit-Rite, Inc. · 2009
  5. 1 generation backK101906 Shape to Fit Compression WearTsung Hau Technology Co., Ltd. · 2010
  6. This deviceK123085 Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM)…3M Company · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K955138Anti-EM/GP StockingsJobst Institute, Inc.1995—
−4K032325Jobst Travel SocksBsn-Jobst, Inc.2003—
−3K040353Flight SockSsl Americas, Inc.2004—
−2K091141Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's Trouser SocksKnit-Rite, Inc.2009—
−1K101906Shape to Fit Compression WearTsung Hau Technology Co., Ltd.2010—
0 (this device)K123085Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM) Travel…3M Company2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
200710
FIG. 1 — Lineage of K123085, 1995–2012Source: 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 DWL? 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
*K032325Jobst Travel Socks
Summary page 2
…ication Panel: General Hospital Product Code: DWL 15 Predicate Devices: K032325 Travel Sock - BSN-Jobst, Inc. K101906 Shape to Fit Compression Socks- Tsung Hau Technology Company, Limited Indications for use:…
Bsn-Jobst, Inc.2003—
*K101906Shape to Fit Compression Wear
Summary page 2
…ospital Product Code: DWL 15 Predicate Devices: K032325 Travel Sock - BSN-Jobst, Inc. K101906 Shape to Fit Compression Socks- Tsung Hau Technology Company, Limited Indications for use: Help prevent edema and leg discomfor…
Tsung Hau Technology Co., Ltd.2010—

Also cleared against K032325: 6 other devices →

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 17 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
  • None of the 7 ancestors has a recall.
  • 6 other devices also cite its predicate K032325.

How does its category compare?

All DWL devices

DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · DWL

1in 2014

2007: 12009: 22010: 32011: 22012: 52013: 32014: 1
2007high 5 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWL

111in 2013

2010: 214 days median2012: 43 days median2013: 111 days median
2007high 214 (2010) · low 43 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DWL

No recall names DWL since 2007.

Adverse event reports per year · DWL

2in 2025

2007: 12009: 32010: 72011: 42012: 102013: 42014: 22015: 12017: 42018: 22019: 12020: 32021: 22022: 12023: 22025: 2
2007high 10 (2012) · low 0 (2008)2025

MAUDE reports naming product code DWL, 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
20071—01
20080—00
20092—03
2010321407
20112—04
2012543010
2013311104
20141—02
20150—01
20160—00
20170—04
20180—02
20190—01
20200—03
20210—02
20220—01
20230—02
20240—00
20250—02
20260—0—

What is it indicated for?

Help prevent edema and leg discomfort and help prevent deep vein thrombosis in individuals subjected to immobility or long distance travel.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K123085: Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM) Travel Stockings; Futuro (TM) Travel Pantyhose.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123085

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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