Cleared Traditional

K874107 - H.T.U. (HYPERBARIC THERAPY UNIT) (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K874107 · Hyox Systems C/O Mechidyne Systems, Inc. · Anesthesiology device
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Dec 1987
Decision
59d
Days
Class 2
Risk

K874107 is an FDA 510(k) clearance for the H.T.U. (HYPERBARIC THERAPY UNIT). Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Hyox Systems C/O Mechidyne Systems, Inc. (Houston, US). The FDA issued a Cleared decision on December 7, 1987 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5470 - the FDA anesthesiology and respiratory 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 Hyox Systems C/O Mechidyne Systems, Inc. devices

Submission Details

510(k) Number K874107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1987
Decision Date December 07, 1987
Days to Decision 59 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 139d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBF Chamber, Hyperbaric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5470
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 Anesthesiology devices follow this clearance model.