Cleared Traditional

BK-1499 KAY-KPLINT HAND CONE/BK-1500 (K801707) - FDA 510(k) Clearance

Class I Physical Medicine device.

K801707 · Fred Sammons, Inc. · Physical Medicine device
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Aug 1980
Decision
27d
Days
Class 1
Risk

K801707 is an FDA 510(k) clearance for the BK-1499 KAY-KPLINT HAND CONE/BK-1500. Classified as Splint, Hand, And Components (product code ILH), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1980 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3475 - 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 K801707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1980
Decision Date August 20, 1980
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ILH Splint, Hand, And Components
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3475
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 - ILH Splint, Hand, And Components

All 22
Devices cleared under the same product code (ILH) and FDA review panel - the closest regulatory comparables to K801707.
WIRE-FOAM MP FLEXION SPRING
K821637 · Fred Sammons, Inc. · Jun 1982
HAND SPLINTS & COMPONENTS
K812349 · Fred Sammons, Inc. · Sep 1981
HAND SPLINTS AND COMPONENTS
K810442 · Fred Sammons, Inc. · Mar 1981
TRANS DISTAL JOINT FINGER EXTEN. SPLINT
K801714 · Fred Sammons, Inc. · Aug 1980
DYNAMIC EXTENSOR SPLINT
K800143 · Biomet, Inc. · Feb 1980
2 VELCRO SPLINT STRAP
K790182 · Fred Sammons, Inc. · Feb 1979