Cleared Traditional

K960931 - CAROLINA NARROW FABRIC COMPANY OPEN TOE ANTI-EMBOLISM STOCKING

K960931 is an FDA 510(k) clearance for CAROLINA NARROW FABRIC COMPANY OPEN TOE..., manufactured by Carolina Narrow Fabric Co.. The device is a Class 2 General Hospital device with product code DWL cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K960931 · Carolina Narrow Fabric Co. · General Hospital
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May 1996
Decision
77d
Days
Class 2
Risk

K960931 is an FDA 510(k) clearance for the CAROLINA NARROW FABRIC COMPANY OPEN TOE ANTI-EMBOLISM STOCKING. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Carolina Narrow Fabric Co. (Winston Salem, US). The FDA issued a Cleared decision on May 23, 1996 after a review of 77 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 Carolina Narrow Fabric Co. devices

FDA 510(k) Submission Details - K960931

510(k) Number K960931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1996
Decision Date May 23, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
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 21
Devices cleared under the same product code (DWL) and FDA review panel - the closest regulatory comparables to K960931.
GEEN MEDISOX
K981296 · Geen Healthcare, Inc. · May 1998
OLYMPIQUE MEDICAL SUPPORT HOSE AND STOCKINGS
K964103 · Tournier-Bottu S.A. · Jan 1997
ELVAREX
K963573 · Jobst A Beiersdorf Co. · Oct 1996
CAROLINA NARROW FABRIC COMPANY CLOSED TOE ANTI-EMBOLISM STOCKING
K961177 · Carolina Narrow Fabric Co. · Apr 1996
KENDALL HOME RX THERAPEUTIC STOCKING
K925417 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jun 1993
SCD THERAPEUTIC STOCKING SYSTEM
K902497 · Kendall Healthcare Products Co. Div.Of Tyco Health · Aug 1990