Cleared Traditional

VENES II (K811085) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K811085 · Jung Products, Inc. · General Hospital
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May 1981
Decision
10d
Days
Class 2
Risk

K811085 is an FDA 510(k) clearance for the VENES II. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Jung Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1981 after a review of 10 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 Jung Products, Inc. devices

Submission Details

510(k) Number K811085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1981
Decision Date May 01, 1981
Days to Decision 10 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
119d faster than avg
Panel avg: 129d · This submission: 10d
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.