Cleared Traditional

K002795 - MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS

K002795 is an FDA 510(k) clearance for MODEL HYBRID 3200 MONOPLACE, manufactured by Hypertec, Inc.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K002795 · Hypertec, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
90d
Days
Class 2
Risk

K002795 is an FDA 510(k) clearance for the MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Hypertec, Inc. (Deer Field, US). The FDA issued a Cleared decision on December 6, 2000 after a review of 90 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. 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 - K002795

510(k) Number K002795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2000
Decision Date December 06, 2000
Days to Decision 90 days
Submission Type Traditional
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
50d faster than avg
Panel avg: 140d · This submission: 90d
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 68
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K002795.
BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM
K011312 · Khrunichev State Research & Production Space Centr · Jul 2001
SEA-LONG MEDICAL TREATMENT HOOD
K010659 · Sea-Long Medical Systems, Inc. · May 2001
MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
K002794 · Hypertec, Inc. · Dec 2000
GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
K001409 · Hyperbaric Technologies, Inc. · Aug 2000
BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER
K993010 · Environmental Tectonics Corp. · May 2000
SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER
K990927 · Perry Baromedical Corp. · Nov 1999
K002795 · MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS
Download PDF FDA Summary Hypertec, Inc.