Cleared Traditional

K800108 - BASHAW CERVICAL IMMOBILIZER DEVICE

K800108 is an FDA 510(k) clearance for BASHAW CERVICAL IMMOBILIZER DEVICE, manufactured by Bashaw Custom Specialties, Inc.. The device is a Class 1 Physical Medicine device with product code IQK cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K800108 · Bashaw Custom Specialties, Inc. · Physical Medicine device
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Feb 1980
Decision
44d
Days
Class 1
Risk

K800108 is an FDA 510(k) clearance for the BASHAW CERVICAL IMMOBILIZER DEVICE. Classified as Orthosis, Cervical (product code IQK), Class I - General Controls.

Submitted by Bashaw Custom Specialties, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 29, 1980 after a review of 44 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 - K800108

510(k) Number K800108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1980
Decision Date February 29, 1980
Days to Decision 44 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 116d · This submission: 44d
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 26
Devices cleared under the same product code (IQK) and FDA review panel - the closest regulatory comparables to K800108.
CONPHAR ADJUSTABLE CERVICAL COLLAR
K803147 · Conphar, Inc. · Jan 1981
LOW BACK POSTURE PILLOW
K802442 · Body Therapeutics, Inc. · Oct 1980
RESTRAINT, PROTECTIVE
K801628 · The Owenby Co. · Aug 1980
CERVICAL COLLAR
K780994 · Fox Instruments, Inc. · Jun 1978
COLLAR, CERVICAL, SPLIT
K780136 · Richard'S Medical Equip., Inc. · Jan 1978
NECKSAVER
K760644 · Health Saver Corp. · Feb 1977
K800108 · BASHAW CERVICAL IMMOBILIZER DEVICE
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