Cleared Traditional

K951234 - MEDICAL SUPPORT STOCKINGS

K951234 is an FDA 510(k) clearance for MEDICAL SUPPORT STOCKINGS, 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 59-day FDA review.

K951234 · Jobst A Beiersdorf Co. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
59d
Days
Class 2
Risk

K951234 is an FDA 510(k) clearance for the MEDICAL SUPPORT STOCKINGS. 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 May 18, 1995 after a review of 59 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 - K951234

510(k) Number K951234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1995
Decision Date May 18, 1995
Days to Decision 59 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
70d faster than avg
Panel avg: 129d · This submission: 59d
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 K951234.
CAROLINA NARROW FABRIC COMPANY CLOSED TOE ANTI-EMBOLISM STOCKING
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K954295 · Professional Products, Inc. · Nov 1995
MEDICAL SUPPORT STOCKINGS 2001/2002
K943734 · Julius Zorn, Inc. · Oct 1994
MEDI STRUMPF
K941926 · Medi USA, LP · Jun 1994
JOBST-CUSTOM
K925154 · Jobst Institute, Inc. · Apr 1994
K951234 · MEDICAL SUPPORT STOCKINGS
Download PDF FDA Summary Jobst A Beiersdorf Co.