Cleared Special

K060739 - MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K060739 · Khrunichev State Research & Production Space Centr · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Jul 2006
Decision
123d
Days
Class 2
Risk

K060739 is an FDA 510(k) clearance for the MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Khrunichev State Research & Production Space Centr (Deer Field, US). The FDA issued a Cleared decision on July 21, 2006 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5470 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Khrunichev State Research & Production Space Centr devices

Submission Details

510(k) Number K060739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2006
Decision Date July 21, 2006
Days to Decision 123 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 139d · This submission: 123d
Pathway characteristics
Modification to existing cleared device.

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.