Cleared Traditional

K123398 - DR. SCHOLL'S COMPRESSION SOCKS

K123398 is an FDA 510(k) clearance for DR. SCHOLL'S COMPRESSION SOCKS, manufactured by Renfro Corporation. The device is a Class 2 General Hospital device with product code DWL cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K123398 · Renfro Corporation · General Hospital
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Optimized for regulatory review, auditing and printing
Dec 2012
Decision
43d
Days
Class 2
Risk

K123398 is an FDA 510(k) clearance for the DR. SCHOLL'S COMPRESSION SOCKS. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Renfro Corporation (Mount Airy, US). The FDA issued a Cleared decision on December 18, 2012 after a review of 43 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.

View all Renfro Corporation devices

FDA 510(k) Submission Details - K123398

510(k) Number K123398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2012
Decision Date December 18, 2012
Days to Decision 43 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
86d faster than avg
Panel avg: 129d · This submission: 43d
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 24
Devices cleared under the same product code (DWL) and FDA review panel - the closest regulatory comparables to K123398.
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
FUTURO (TM) TRAVEL KNEE-HIGHS
K123085 · 3M Company · 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
CURAD COMPRESSION HOSIERY
K112769 · Medline Industries, Inc. · Mar 2012