Cleared Traditional

K123820 - BOSSONG HOSIERY MEDICAL COMPRESSION STO...

K123820 is the FDA 510(k) clearance for BOSSONG HOSIERY MEDICAL COMPRESSION STO... by Bossong Hosiery Mills, Inc.. It is a Class 2 General Hospital device (product code DWL) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K123820 · Bossong Hosiery Mills, Inc. · General Hospital
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Apr 2013
Decision
111d
Days
Class 2
Risk

K123820 is an FDA 510(k) clearance for the BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI.... Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Bossong Hosiery Mills, Inc. (Hickory, US). The FDA issued a Cleared decision on April 2, 2013 after a review of 111 days - within the typical 510(k) review window.

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 Bossong Hosiery Mills, Inc. devices

Submission Details

510(k) Number K123820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2012
Decision Date April 02, 2013
Days to Decision 111 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 129d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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
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