Cleared Traditional

K051540 - INOVO

K051540 is an FDA 510(k) clearance for INOVO, manufactured by Inovo, Inc.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K051540 · Inovo, Inc. · Anesthesiology device
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Sep 2005
Decision
103d
Days
Class 2
Risk

K051540 is an FDA 510(k) clearance for the INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Inovo, Inc. (Naples, US). The FDA issued a Cleared decision on September 21, 2005 after a review of 103 days - within the typical 510(k) review window.

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.

View all Inovo, Inc. devices

FDA 510(k) Submission Details - K051540

510(k) Number K051540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2005
Decision Date September 21, 2005
Days to Decision 103 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
37d faster than avg
Panel avg: 140d · This submission: 103d
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 K051540.
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