Cleared Traditional

K874107 - H.T.U. (HYPERBARIC THERAPY UNIT)

K874107 is an FDA 510(k) clearance for H.T.U. (HYPERBARIC THERAPY UNIT), manufactured by Hyox Systems C/O Mechidyne Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K874107 · Hyox Systems C/O Mechidyne Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K874107

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
81d faster than avg
Panel avg: 140d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBF Device Classification - Class 2, Special Controls

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.

Regulatory Peers - CBF Chamber, Hyperbaric

All 61
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K874107.
LAB-SITE(R) SAFETY CANNULA
K933929 · Migada, Ltd. · Dec 1993
SIGMA MP MULTIPLACE HYPERBARIC CHAMBER
K930748 · Perry Baromedical Services · Aug 1993
HYPERLITE
K905168 · S.O.S. , Ltd. · Jul 1991
HYPERBARIC PENETRATION EXTENSION SET
K861315 · Cutter Laboratories, Inc. · May 1986
MICROSPAN -PH MONITOR
K842303 · Biochem International, Inc. · Oct 1984
K874107 · H.T.U. (HYPERBARIC THERAPY UNIT)
Download PDF Hyox Systems C/O Mech…