Cleared Traditional

K984313 - HTU3

K984313 is an FDA 510(k) clearance for HTU3, manufactured by Hyox Systems , Ltd.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K984313 · Hyox Systems , Ltd. · Anesthesiology device
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Oct 1999
Decision
324d
Days
Class 2
Risk

K984313 is an FDA 510(k) clearance for the HTU3. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Hyox Systems , Ltd. (Washington, US). The FDA issued a Cleared decision on October 22, 1999 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hyox Systems , Ltd. devices

FDA 510(k) Submission Details - K984313

510(k) Number K984313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1998
Decision Date October 22, 1999
Days to Decision 324 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 140d · This submission: 324d
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 22
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K984313.
MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER
K052713 · Sechrist Industries, Inc. · Oct 2005
BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER
K993010 · Environmental Tectonics Corp. · May 2000
SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER
K990927 · Perry Baromedical Corp. · Nov 1999
TAMPA HYPERBARIC MONOPLACE CHAMBER
K981938 · Tampa Hyperbaric Ent. · Jul 1999
SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM
K983648 · Perry Baromedical Services · Feb 1999
SANDS SERIES III HYPERBARIC CHAMBER
K972908 · Sands Hyperbarics · Jul 1998