Cleared Traditional

K960389 - HYPERBARIC CHAMBER

K960389 is an FDA 510(k) clearance for HYPERBARIC CHAMBER, manufactured by Tampa Hyperbaric Ent.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K960389 · Tampa Hyperbaric Ent. · Anesthesiology device
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Dec 1996
Decision
318d
Days
Class 2
Risk

K960389 is an FDA 510(k) clearance for the HYPERBARIC CHAMBER. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Tampa Hyperbaric Ent. (Tampa, US). The FDA issued a Cleared decision on December 5, 1996 after a review of 318 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 Tampa Hyperbaric Ent. devices

FDA 510(k) Submission Details - K960389

510(k) Number K960389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1996
Decision Date December 05, 1996
Days to Decision 318 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
178d slower than avg
Panel avg: 140d · This submission: 318d
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 K960389.
SANDS SERIES III HYPERBARIC CHAMBER
K972908 · Sands Hyperbarics · Jul 1998
SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER
K974868 · Perry Baromedical Corp. · Jul 1998
WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM
K952545 · Wright Industries · May 1997
GSP1 - GAS SELECTION PANEL
K962869 · Reimers Systems, Inc. · Oct 1996
ODS1 - HOOD DRIVER
K962871 · Reimers Systems, Inc. · Oct 1996
LOUISVILLE LABS OXYGEN HEAD TENT
K955535 · Louisville Laboratories, Inc. · Jul 1996