Cleared Special

K060739 - MONOPLACE HYPERBARIC OXYGEN TREATMENT S...

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)
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

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
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 10
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K060739.
Revitalair 430F
K171899 · Oxavita Srl · Nov 2019
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
K140559 · Sechrist Industries, Inc. · May 2014
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
K100268 · Sechrist Industries, Inc. · Apr 2010
MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER
K052713 · Sechrist Industries, Inc. · Oct 2005
MODEL 2500E/2500ER HYPERBARIC CHAMBER
K934164 · Sechrist Industries, Inc. · Jun 1995
MODEL 3200P/3200PR HYPERBARIC CHAMBER
K950386 · Sechrist Industries, Inc. · Jun 1995