Cleared Traditional

K123085 - FUTURO (TM) TRAVEL KNEE-HIGHS

Also marketed or referenced as:
FUTURO (TM) TRAVEL SOCKS FUTURO (TM) TRAVEL STOCKINGS FUTURO (TM) TRAVEL PANTYHOSE

K123085 is an FDA 510(k) clearance for FUTURO (TM) TRAVEL KNEE-HIGHS, manufactured by 3M Company. The device is a Class 2 General Hospital device with product code DWL cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K123085 · 3M Company · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
80d
Days
Class 2
Risk

K123085 is an FDA 510(k) clearance for the FUTURO (TM) TRAVEL KNEE-HIGHS. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by 3M Company (Saint Paul, US). The FDA issued a Cleared decision on December 20, 2012 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5780 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K123085

510(k) Number K123085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2012
Decision Date December 20, 2012
Days to Decision 80 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 129d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWL Device Classification - Class 2, Special Controls

Product Code DWL Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - DWL Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)

All 50
Devices cleared under the same product code (DWL) and FDA review panel - the closest regulatory comparables to K123085.
BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)
K131496 · Bsn Medical, Inc. · Jul 2013
ENCIRCLE COMPRESSION THERAPY STOCKING
K122485 · Encircle Medical Devices , Ltd. · Apr 2013
BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS
K123820 · Bossong Hosiery Mills, Inc. · Apr 2013
DR. SCHOLL'S COMPRESSION SOCKS
K123398 · Renfro Corporation · Dec 2012
ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS
K123561 · Bsn Medical, Inc. · Dec 2012
TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET
K121106 · Surgical Appliance Industries, Inc. · Apr 2012
K123085 · FUTURO (TM) TRAVEL KNEE-HIGHS
Download PDF FDA Summary 3M Company