Cleared Traditional

JOBST READY-TO-WEAR ARM SLEEVES (K991570) - FDA 510(k) Clearance

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

K991570 · Beiersdorf-Jobt, Inc. · General Hospital
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Aug 1999
Decision
107d
Days
Class 2
Risk

K991570 is an FDA 510(k) clearance for the JOBST READY-TO-WEAR ARM SLEEVES. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Beiersdorf-Jobt, Inc. (Charlotte, US). The FDA issued a Cleared decision on August 20, 1999 after a review of 107 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 Beiersdorf-Jobt, Inc. devices

Submission Details

510(k) Number K991570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1999
Decision Date August 20, 1999
Days to Decision 107 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
22d faster than avg
Panel avg: 129d · This submission: 107d
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.