Cleared Traditional

K841368 - HYPERBARIC OXYGEN GURNEY-

K841368 is an FDA 510(k) clearance for HYPERBARIC OXYGEN GURNEY-, manufactured by Orthopedic Systems, Inc.. The device is a Class 1 Neurology device with product code HST cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K841368 · Orthopedic Systems, Inc. · Neurology device
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May 1984
Decision
43d
Days
Class 1
Risk

K841368 is an FDA 510(k) clearance for the HYPERBARIC OXYGEN GURNEY-. Classified as Apparatus, Traction, Non-powered (product code HST), Class I - General Controls.

Submitted by Orthopedic Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 16, 1984 after a review of 43 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 Orthopedic Systems, Inc. devices

FDA 510(k) Submission Details - K841368

510(k) Number K841368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1984
Decision Date May 16, 1984
Days to Decision 43 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 148d · This submission: 43d
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 13
Devices cleared under the same product code (HST) and FDA review panel - the closest regulatory comparables to K841368.
EXTREMITY ELEVATOR
K870125 · Orthopedic Systems, Inc. · Feb 1987
TUPPER TROLLEY
K870102 · Orthopedic Systems, Inc. · Feb 1987
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