Cleared Traditional

K963573 - ELVAREX

K963573 is an FDA 510(k) clearance for ELVAREX, manufactured by Jobst A Beiersdorf Co.. The device is a Class 2 General Hospital device with product code DWL cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K963573 · Jobst A Beiersdorf Co. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
41d
Days
Class 2
Risk

K963573 is an FDA 510(k) clearance for the ELVAREX. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Jobst A Beiersdorf Co. (Charlotte, US). The FDA issued a Cleared decision on October 16, 1996 after a review of 41 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 - K963573

510(k) Number K963573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1996
Decision Date October 16, 1996
Days to Decision 41 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
88d faster than avg
Panel avg: 129d · This submission: 41d
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 K963573.
JOBST READY-TO-WEAR ARM SLEEVES
K991570 · Beiersdorf-Jobt, Inc. · Aug 1999
GEEN MEDISOX
K981296 · Geen Healthcare, Inc. · May 1998
OLYMPIQUE MEDICAL SUPPORT HOSE AND STOCKINGS
K964103 · Tournier-Bottu S.A. · Jan 1997
CAROLINA NARROW FABRIC COMPANY OPEN TOE ANTI-EMBOLISM STOCKING
K960931 · Carolina Narrow Fabric Co. · May 1996
CAROLINA NARROW FABRIC COMPANY CLOSED TOE ANTI-EMBOLISM STOCKING
K961177 · Carolina Narrow Fabric Co. · Apr 1996
ANTI-EM/GP STOCKINGS
K955138 · Jobst Institute, Inc. · Dec 1995
K963573 · ELVAREX
Download PDF FDA Summary Jobst A Beiersdorf Co.