Cleared Traditional

K052563 - INOGEN SATELLITE CONSERVER

K052563 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 35-day FDA review.

K052563 · Medical Electronic Devices, Inc. · Anesthesiology device
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Oct 2005
Decision
35d
Days
Class 2
Risk

K052563 is an FDA 510(k) clearance for the INOGEN SATELLITE CONSERVER, MODEL SC-100. 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 October 24, 2005 after a review of 35 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medical Electronic Devices, Inc. devices

FDA 510(k) Submission Details - K052563

510(k) Number K052563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2005
Decision Date October 24, 2005
Days to Decision 35 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 140d · This submission: 35d
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 20
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K052563.
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
K221014 · Effortless Oxygen, LLC · Oct 2022
Apogee
K200401 · Incoba Ltd D/B/A Dynaris · Nov 2020
Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
K151506 · Salter Labs · Mar 2016
EOCD
K041568 · Respironics, Inc. · Jul 2004
EASY PULSE II OXYGEN CONSERVER
K032018 · Precision Medical, Inc. · Aug 2003
AIRLIFE DEMAND NASAL CANNULA
K023673 · Allegiance Healthcare Corp. · May 2003