Cleared Traditional

K013852 - JOBST READY-TO-WEAR GAUNTLET

K013852 is an FDA 510(k) clearance for JOBST READY-TO-WEAR GAUNTLET, manufactured by Bsn-Jobst, Inc.. The device is a Class 2 General Hospital device with product code DWL cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K013852 · Bsn-Jobst, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
69d
Days
Class 2
Risk

K013852 is an FDA 510(k) clearance for the JOBST READY-TO-WEAR GAUNTLET. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Bsn-Jobst, Inc. (Charlotte, US). The FDA issued a Cleared decision on January 28, 2002 after a review of 69 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.

View all Bsn-Jobst, Inc. devices

FDA 510(k) Submission Details - K013852

510(k) Number K013852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2001
Decision Date January 28, 2002
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
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 22
Devices cleared under the same product code (DWL) and FDA review panel - the closest regulatory comparables to K013852.
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