Cleared Traditional

BK-2082 FOLDING STOCKING AID (K821856) - FDA 510(k) Clearance

Class I Physical Medicine device.

K821856 · Fred Sammons, Inc. · Physical Medicine device
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Jul 1982
Decision
9d
Days
Class 1
Risk

K821856 is an FDA 510(k) clearance for the BK-2082 FOLDING STOCKING AID. Classified as Adaptor, Dressing (product code ILD), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 2, 1982 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5050 - the FDA physical medicine 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 Fred Sammons, Inc. devices

Submission Details

510(k) Number K821856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1982
Decision Date July 02, 1982
Days to Decision 9 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 115d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ILD Adaptor, Dressing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5050
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ILD Adaptor, Dressing

All 13
Devices cleared under the same product code (ILD) and FDA review panel - the closest regulatory comparables to K821856.
LEATHER I VELCRO SHOE FASTENER REPAIR
K823627 · Fred Sammons, Inc. · Dec 1982
LEATHER & VELCRO SHOE FASTENER
K823628 · Fred Sammons, Inc. · Dec 1982
REGULAR SHOE HORN W/CYLINDRICAL HANDLE
K823602 · Fred Sammons, Inc. · Dec 1982
NOTIE STRETCH-LACE-VARIOUS MODELS
K821858 · Fred Sammons, Inc. · Jul 1982
ORTHOLACE 4,5.6 EYELET
K821859 · Fred Sammons, Inc. · Jul 1982
ONE HANDED SHOE FASTENER
K813634 · Fred Sammons, Inc. · Jan 1982