Cleared Traditional

K905631 - COMPRINET, COMTESSE AND BELLAVAR STOCKINGS

K905631 is an FDA 510(k) clearance for COMPRINET, manufactured by Jobst Institute, Inc.. The device is a Class 2 General Hospital device with product code DWL cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K905631 · Jobst Institute, Inc. · General Hospital
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Mar 1991
Decision
80d
Days
Class 2
Risk

K905631 is an FDA 510(k) clearance for the COMPRINET, COMTESSE AND BELLAVAR STOCKINGS. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Jobst Institute, Inc. (Toledo, US). The FDA issued a Cleared decision on March 7, 1991 after a review of 80 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 Jobst Institute, Inc. devices

FDA 510(k) Submission Details - K905631

510(k) Number K905631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1990
Decision Date March 07, 1991
Days to Decision 80 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 129d · This submission: 80d
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 26
Devices cleared under the same product code (DWL) and FDA review panel - the closest regulatory comparables to K905631.
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SCD THERAPEUTIC STOCKING SYSTEM
K902497 · Kendall Healthcare Products Co. Div.Of Tyco Health · Aug 1990
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