Cleared Traditional

COMFORT SHEER FIRM AND SHEER SUPPORT PANTYHOSE (K894071) - FDA 510(k) Clearance

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

K894071 · Sara Lee Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
132d
Days
Class 2
Risk

K894071 is an FDA 510(k) clearance for the COMFORT SHEER FIRM AND SHEER SUPPORT PANTYHOSE. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Sara Lee Corp. (Winston-Salem, US). The FDA issued a Cleared decision on October 18, 1989 after a review of 132 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 Sara Lee Corp. devices

Submission Details

510(k) Number K894071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1989
Decision Date October 18, 1989
Days to Decision 132 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
3d slower than avg
Panel avg: 129d · This submission: 132d
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.