Cleared Traditional

K991570 - JOBST READY-TO-WEAR ARM SLEEVES

K991570 is an FDA 510(k) clearance for JOBST READY-TO-WEAR ARM SLEEVES, manufactured by Beiersdorf-Jobt, Inc.. The device is a Class 2 General Hospital device with product code DWL cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K991570 · Beiersdorf-Jobt, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K991570

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
Combination Product No
PCCP Authorized No
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.

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 50
Devices cleared under the same product code (DWL) and FDA review panel - the closest regulatory comparables to K991570.
ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001
K020592 · Alba-Waldensian, Inc. · Apr 2002
JOBST READY-TO-WEAR GAUNTLET
K013852 · Bsn-Jobst, Inc. · Jan 2002
D. R. MEDICAL CONTROLLED PRESSURE GARMENTS
K001300 · Confection Medicale D.R., Inc. · Aug 2000
GEEN MEDISOX
K981296 · Geen Healthcare, Inc. · May 1998
OLYMPIQUE MEDICAL SUPPORT HOSE AND STOCKINGS
K964103 · Tournier-Bottu S.A. · Jan 1997
ELVAREX
K963573 · Jobst A Beiersdorf Co. · Oct 1996
K991570 · JOBST READY-TO-WEAR ARM SLEEVES
Download PDF FDA Summary Beiersdorf-Jobt, Inc.