Cleared Traditional

K033197 - INOGEN SATELLITE CONSERVER

K033197 is an FDA 510(k) clearance for INOGEN SATELLITE CONSERVER, manufactured by Medical Electronic Devices, Inc.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K033197 · Medical Electronic Devices, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
224d
Days
Class 2
Risk

K033197 is an FDA 510(k) clearance for the INOGEN SATELLITE CONSERVER. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Medical Electronic Devices, Inc. (Torrance, US). The FDA issued a Cleared decision on May 13, 2004 after a review of 224 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 - K033197

510(k) Number K033197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2003
Decision Date May 13, 2004
Days to Decision 224 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
84d slower than avg
Panel avg: 140d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFB Device Classification - Class 2, Special Controls

Product Code NFB Conserver, Oxygen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - NFB Conserver, Oxygen

All 62
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K033197.
CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S
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FLO-RITE
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EOCD
K041568 · Respironics, Inc. · Jul 2004
CHAD THERAPEUTICS SAGE
K033364 · Chad Therapeutics, Inc. · May 2004
ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER
K024023 · Essex Medical Systems Plus · Oct 2003
INOVO, INC, ECONOMIZER CONSERVING REGULATOR
K031983 · Inovo, Inc. · Sep 2003