Cleared Traditional

K860037 - SUSPENDER ORTHOPEDIC SUSPENSION DEVICE

K860037 is an FDA 510(k) clearance for SUSPENDER ORTHOPEDIC SUSPENSION DEVICE, 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 15-day FDA review.

K860037 · Comfortex, Inc. · Neurology device
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Jan 1986
Decision
15d
Days
Class 1
Risk

K860037 is an FDA 510(k) clearance for the SUSPENDER ORTHOPEDIC SUSPENSION DEVICE. 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 15 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 - K860037

510(k) Number K860037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1986
Decision Date January 21, 1986
Days to Decision 15 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 148d · This submission: 15d
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 K860037.
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