Cleared Traditional

K051324 - MEDI BUTLER

K051324 is an FDA 510(k) clearance for MEDI BUTLER, manufactured by Medi USA, LP. The device is a Class 2 General Hospital device with product code DWL cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K051324 · Medi USA, LP · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
199d
Days
Class 2
Risk

K051324 is an FDA 510(k) clearance for the MEDI BUTLER. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Medi USA, LP (Washington, US). The FDA issued a Cleared decision on December 5, 2005 after a review of 199 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 Medi USA, LP devices

FDA 510(k) Submission Details - K051324

510(k) Number K051324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2005
Decision Date December 05, 2005
Days to Decision 199 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 129d · This submission: 199d
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 9
Devices cleared under the same product code (DWL) and FDA review panel - the closest regulatory comparables to K051324.
FUTURO (TM) TRAVEL KNEE-HIGHS
K123085 · 3M Company · Dec 2012
CURAD COMPRESSION HOSIERY
K112769 · Medline Industries, Inc. · Mar 2012
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K090921 · Beiersdorf, Inc. · Dec 2009
BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES
K020538 · Boehringer Laboratories · May 2002
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