Cleared Traditional

K864746 - BREMER HALO SYSTEM

K864746 is an FDA 510(k) clearance for BREMER HALO SYSTEM, manufactured by Bremer Orthopedics. The device is a Class 2 Neurology device with product code HAX cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K864746 · Bremer Orthopedics · Neurology device
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Dec 1986
Decision
17d
Days
Class 2
Risk

K864746 is an FDA 510(k) clearance for the BREMER HALO SYSTEM. Classified as Tong, Skull For Traction (product code HAX), Class II - Special Controls.

Submitted by Bremer Orthopedics (Jacksonville, US). The FDA issued a Cleared decision on December 22, 1986 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5960 - the FDA neurology 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 Bremer Orthopedics devices

FDA 510(k) Submission Details - K864746

510(k) Number K864746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1986
Decision Date December 22, 1986
Days to Decision 17 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 148d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAX Device Classification - Class 2, Special Controls

Product Code HAX Tong, Skull For Traction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5960
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 Neurology devices follow this clearance model.

Regulatory Peers - HAX Tong, Skull For Traction

All 12
Devices cleared under the same product code (HAX) and FDA review panel - the closest regulatory comparables to K864746.
ACE CERVICAL TRACTION HALOZS, TONGS & PINS
K954069 · Ace Medical Co. · Oct 1995
NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE
K915530 · American Threshold Industries, Inc. · Aug 1992
PMT TRACTION TONGS
K871663 · Progress Mankind Technology · Jun 1987
MAYFIELD DISPOSABLE SKULL PINS
K853066 · Codman & Shurtleff, Inc. · Aug 1985
ACE UNIVERSAL TONG
K842680 · Buckman Co., Inc. · Sep 1984
PMT-HALO/ORTHOPEDIC JACKET SYSTEM
K834047 · Progress Mankind Technology · Feb 1984