Cleared Traditional

K925417 - KENDALL HOME RX THERAPEUTIC STOCKING

K925417 is an FDA 510(k) clearance for KENDALL HOME RX THERAPEUTIC STOCKING, manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 2 General Hospital device with product code DWL cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K925417 · Kendall Healthcare Products Co. Div.Of Tyco Health · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
220d
Days
Class 2
Risk

K925417 is an FDA 510(k) clearance for the KENDALL HOME RX THERAPEUTIC STOCKING. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on June 4, 1993 after a review of 220 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K925417

510(k) Number K925417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1992
Decision Date June 04, 1993
Days to Decision 220 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
91d slower than avg
Panel avg: 129d · This submission: 220d
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 39
Devices cleared under the same product code (DWL) and FDA review panel - the closest regulatory comparables to K925417.
MEDI STRUMPF
K941926 · Medi USA, LP · Jun 1994
JOBST-CUSTOM
K925154 · Jobst Institute, Inc. · Apr 1994
RX FIT MEDICAL STOCKINGS
K925643 · Elastic Therapy, Inc. · Dec 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