Cleared Traditional

K051007 - ACCU02 SYSTEM

K051007 is an FDA 510(k) clearance for ACCU02 SYSTEM, manufactured by Miti Corp.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K051007 · Miti Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
57d
Days
Class 2
Risk

K051007 is an FDA 510(k) clearance for the ACCU02 SYSTEM. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Miti Corp. (Washington, US). The FDA issued a Cleared decision on June 16, 2005 after a review of 57 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 Miti Corp. devices

FDA 510(k) Submission Details - K051007

510(k) Number K051007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2005
Decision Date June 16, 2005
Days to Decision 57 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
83d faster than avg
Panel avg: 140d · This submission: 57d
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 46
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K051007.
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION
K113111 · Inovo, Inc. · Dec 2011
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER
K103392 · Inovo, Inc. · Dec 2010
CHAD THERAPEUTICS BONSAI MODEL 800
K070740 · Chad Therapeutics, Inc. · May 2007
CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S
K042142 · Chad Therapeutics, Inc. · Sep 2004
EOCD
K041568 · Respironics, Inc. · Jul 2004
CHAD THERAPEUTICS SAGE
K033364 · Chad Therapeutics, Inc. · May 2004