Cleared Traditional

K831888 - COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG

K831888 is the FDA 510(k) clearance for COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG by Portable Travtion Device Co.. It is a Class 1 Neurology device (product code HST) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K831888 · Portable Travtion Device Co. · Neurology device
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Jul 1983
Decision
29d
Days
Class 1
Risk

K831888 is an FDA 510(k) clearance for the COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG. Classified as Apparatus, Traction, Non-powered (product code HST), Class I - General Controls.

Submitted by Portable Travtion Device Co. (Walker, US). The FDA issued a Cleared decision on July 12, 1983 after a review of 29 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 Portable Travtion Device Co. devices

Submission Details

510(k) Number K831888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1983
Decision Date July 12, 1983
Days to Decision 29 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 14
Devices cleared under the same product code (HST) and FDA review panel - the closest regulatory comparables to K831888.
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
K823813 · Danek Medical, Inc. · Jan 1983
OCTAGONAL ALUMINUM FRAMING SYSTEM
K823372 · Orthopedic Systems, Inc. · Dec 1982
TRACTION-STEEL FRAMING SYSTEM
K823395 · Orthopedic Systems, Inc. · Dec 1982