Cleared Abbreviated

K011312 - BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM

K011312 is an FDA 510(k) clearance for BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM, manufactured by Khrunichev State Research & Production Space Centr. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Abbreviated 510(k) pathway after a 79-day FDA review.

K011312 · 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 2001
Decision
79d
Days
Class 2
Risk

K011312 is an FDA 510(k) clearance for the BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Khrunichev State Research & Production Space Centr (San Antonio, US). The FDA issued a Cleared decision on July 18, 2001 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5470 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K011312

510(k) Number K011312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2001
Decision Date July 18, 2001
Days to Decision 79 days
Submission Type Abbreviated
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
61d faster than avg
Panel avg: 140d · This submission: 79d
Pathway characteristics
Standards-based clearance path.

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 K011312.
OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES
K011866 · Hyperbaric Technologies, Inc. · Jun 2002
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
K001121 · Engineered Medical Technology, Inc. · Nov 2001
INFANT OXYGEN TREATMENT HOOD
K011565 · Gulf Coast Hyperbarics, Inc. · Aug 2001
SEA-LONG MEDICAL TREATMENT HOOD
K010659 · Sea-Long Medical Systems, Inc. · May 2001
MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
K002794 · Hypertec, Inc. · Dec 2000
MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS
K002795 · Hypertec, Inc. · Dec 2000