Cleared Traditional

K810024 - BONNER BRACE

K810024 is an FDA 510(k) clearance for BONNER BRACE, manufactured by Bee Ent.. The device is a Class 1 Physical Medicine device with product code IQK cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K810024 · Bee Ent. · Physical Medicine device
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Jan 1981
Decision
18d
Days
Class 1
Risk

K810024 is an FDA 510(k) clearance for the BONNER BRACE. Classified as Orthosis, Cervical (product code IQK), Class I - General Controls.

Submitted by Bee Ent. (Mchenry, US). The FDA issued a Cleared decision on January 23, 1981 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3490 - 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.

FDA 510(k) Submission Details - K810024

510(k) Number K810024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1981
Decision Date January 23, 1981
Days to Decision 18 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
98d faster than avg
Panel avg: 116d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

IQK Device Classification - Class 1, General Controls

Product Code IQK Orthosis, Cervical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3490
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 - IQK Orthosis, Cervical

All 23
Devices cleared under the same product code (IQK) and FDA review panel - the closest regulatory comparables to K810024.
BECSIC COLLAR
K820366 · Blackstone & Breglio Industries · Mar 1982
LOXLEY EMERGENCY CERVICAL COLLAR
K812019 · Loxley Medical · Oct 1981
EXECUTIVE COLLAR
K811298 · Orthomedics · May 1981
CONPHAR ADJUSTABLE CERVICAL COLLAR
K803147 · Conphar, Inc. · Jan 1981
CERVICAL COLLAR
K780994 · Fox Instruments, Inc. · Jun 1978
COLLAR, CERVICAL, SPLIT
K780136 · Richard'S Medical Equip., Inc. · Jan 1978
K810024 · BONNER BRACE
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