Cleared Abbreviated

K001121 - OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)

K001121 is an FDA 510(k) clearance for OXYGEN APPLIED SYMPTOM IMPROVEMENT SYST..., manufactured by Engineered Medical Technology, Inc.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Abbreviated 510(k) pathway after a 601-day FDA review.

K001121 · Engineered Medical Technology, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
601d
Days
Class 2
Risk

K001121 is an FDA 510(k) clearance for the OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS). Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Engineered Medical Technology, Inc. (Victoria, US). The FDA issued a Cleared decision on November 29, 2001 after a review of 601 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

FDA 510(k) Submission Details - K001121

510(k) Number K001121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2000
Decision Date November 29, 2001
Days to Decision 601 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
461d slower than avg
Panel avg: 140d · This submission: 601d
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 68
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K001121.
BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER
K020974 · Environmental Tectonics Corp. · Jun 2002
OXYGEN TREATMENT HOOD
K011592 · Amron International Diving Supply, Inc. · Jun 2002
OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES
K011866 · Hyperbaric Technologies, Inc. · Jun 2002
INFANT OXYGEN TREATMENT HOOD
K011565 · Gulf Coast Hyperbarics, Inc. · Aug 2001
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
K001121 · OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
Download PDF FDA Summary Engineered Medical Te…