Cleared Traditional

K051540 - INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 62
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K051540.
INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR
K060751 · Inovo, Inc. · Jul 2006
FLO-RITE, MODEL 478-1
K060382 · Ameriflo Corp. · Apr 2006
INOGEN SATELLITE CONSERVER, MODEL SC-100
K052563 · Medical Electronic Devices, Inc. · Oct 2005
OXY-SERVE II OXYGEN CONSERVING REGULATOR
K051988 · Superior Products, Inc. · Sep 2005
ACCU02 SYSTEM
K051007 · Miti Corp. · Jun 2005
CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S
K042142 · Chad Therapeutics, Inc. · Sep 2004