Cleared Traditional

K022214 - MSI I2010 DUAL PLACE HYPERBARIC CHAMBER

K022214 is an FDA 510(k) clearance for MSI I2010 DUAL PLACE HYPERBARIC CHAMBER, manufactured by Mechidyne Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K022214 · Mechidyne Systems, Inc. · Anesthesiology device
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Feb 2003
Decision
233d
Days
Class 2
Risk

K022214 is an FDA 510(k) clearance for the MSI I2010 DUAL PLACE HYPERBARIC CHAMBER. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Mechidyne Systems, Inc. (Houston, US). The FDA issued a Cleared decision on February 26, 2003 after a review of 233 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K022214

510(k) Number K022214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2002
Decision Date February 26, 2003
Days to Decision 233 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 140d · This submission: 233d
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 67
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K022214.
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PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1
K021693 · Pan-America Hyperbarics, Inc. · Oct 2002
K022214 · MSI I2010 DUAL PLACE HYPERBARIC CHAMBER
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