Cleared Traditional

K040145 - ATA HCM MONOPLACE HYPERBARIC SYSTEM (FDA 510(k) Clearance)

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

K040145 · Ata Hyperbaric Chamber Manufacturing · Anesthesiology device
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May 2005
Decision
468d
Days
Class 2
Risk

K040145 is an FDA 510(k) clearance for the ATA HCM MONOPLACE HYPERBARIC SYSTEM. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Ata Hyperbaric Chamber Manufacturing (Victoria, Bc, CA). The FDA issued a Cleared decision on May 4, 2005 after a review of 468 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Ata Hyperbaric Chamber Manufacturing devices

Submission Details

510(k) Number K040145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2004
Decision Date May 04, 2005
Days to Decision 468 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
329d slower than avg
Panel avg: 139d · This submission: 468d
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.