Cleared Traditional

K905413 - JUZO-RESPIRA ANTI-EMBOLISM STOCKING

K905413 is an FDA 510(k) clearance for JUZO-RESPIRA ANTI-EMBOLISM STOCKING, manufactured by Julius Zorn, Inc.. The device is a Class 2 General Hospital device with product code DWL cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K905413 · Julius Zorn, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1991
Decision
165d
Days
Class 2
Risk

K905413 is an FDA 510(k) clearance for the JUZO-RESPIRA ANTI-EMBOLISM STOCKING. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Julius Zorn, Inc. (Los Angeles, US). The FDA issued a Cleared decision on May 17, 1991 after a review of 165 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Julius Zorn, Inc. devices

FDA 510(k) Submission Details - K905413

510(k) Number K905413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1990
Decision Date May 17, 1991
Days to Decision 165 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 129d · This submission: 165d
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 26
Devices cleared under the same product code (DWL) and FDA review panel - the closest regulatory comparables to K905413.
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
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
ENHANCE SUPPORT HOSE
K873280 · Kimberly-Clark Corp. · Oct 1987
A.V.R. KNEE LENGTH THERAPEUTIC STOCK-
K832609 · The Kendal Co. · Sep 1983