Cleared Traditional

K855179 - TRANSFER-TRAX (TM) SPLINT TRACTION

K855179 is an FDA 510(k) clearance for TRANSFER-TRAX (TM) SPLINT TRACTION, manufactured by Comfortex, Inc.. The device is a Class 1 Neurology device with product code HST cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K855179 · Comfortex, Inc. · Neurology device
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Jan 1986
Decision
26d
Days
Class 1
Risk

K855179 is an FDA 510(k) clearance for the TRANSFER-TRAX (TM) SPLINT TRACTION. Classified as Apparatus, Traction, Non-powered (product code HST), Class I - General Controls.

Submitted by Comfortex, Inc. (Winona, US). The FDA issued a Cleared decision on January 21, 1986 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.5850 - 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 Comfortex, Inc. devices

FDA 510(k) Submission Details - K855179

510(k) Number K855179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date January 21, 1986
Days to Decision 26 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 148d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

HST Device Classification - Class 1, General Controls

Product Code HST Apparatus, Traction, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5850
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 - HST Apparatus, Traction, Non-powered

All 19
Devices cleared under the same product code (HST) and FDA review panel - the closest regulatory comparables to K855179.
ARTHROSCOPIC SHOULDER HOLDER
K870212 · Dyonics, Inc. · Feb 1987
EXTREMITY ELEVATOR
K870125 · Orthopedic Systems, Inc. · Feb 1987
TUPPER TROLLEY
K870102 · Orthopedic Systems, Inc. · Feb 1987
HYPERBARIC OXYGEN GURNEY-
K841368 · Orthopedic Systems, Inc. · May 1984
ACUFEX SHOULDER HOLDER
K841388 · Acufex Microsurgical, Inc. · May 1984
TRACTION ACCESSORIES
K830244 · Warm & Form, Orthopedic Materials · Mar 1983