Cleared Special

K060739 - MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307

K060739 is an FDA 510(k) clearance for MONOPLACE HYPERBARIC OXYGEN TREATMENT S..., manufactured by Khrunichev State Research & Production Space Centr. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Special 510(k) pathway after a 123-day FDA review.

K060739 · Khrunichev State Research & Production Space Centr · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K060739

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 140d · This submission: 123d
Pathway characteristics
Modification to existing cleared device.

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 56
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K060739.
HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS
K081506 · Hyperbaric America, LLC · Jul 2008
SIGMA SERIES HYPERBARIC CHAMBER
K072427 · Perry Baromedical Corp. · Jun 2008
DIVE AND SHALLOW AND GRAND DIVE
K072757 · Summit TO Sea · Feb 2008
HYPEROX 101
K053498 · Wjo, Inc. · Mar 2006
OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER
K052866 · Oxyheal Health Group · Dec 2005
FLEXI-LITE, MODEL FL-V1.2
K051759 · Performance Hyperbarics · Nov 2005