Cleared Traditional

K061901 - INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003

K061901 is an FDA 510(k) clearance for INO THERAPEUTICS INOMAX DS (DELIVERY SY..., manufactured by Ino Therapeutics. The device is a Class 2 Anesthesiology device with product code MRN cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K061901 · Ino Therapeutics · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
162d
Days
Class 2
Risk

K061901 is an FDA 510(k) clearance for the INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003. Classified as Apparatus, Nitric Oxide Delivery (product code MRN), Class II - Special Controls.

Submitted by Ino Therapeutics (Middleton, US). The FDA issued a Cleared decision on December 14, 2006 after a review of 162 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5165 - 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 - K061901

510(k) Number K061901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2006
Decision Date December 14, 2006
Days to Decision 162 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
22d slower than avg
Panel avg: 140d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRN Device Classification - Class 2, Special Controls

Product Code MRN Apparatus, Nitric Oxide Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5165
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 - MRN Apparatus, Nitric Oxide Delivery

All 32
Devices cleared under the same product code (MRN) and FDA review panel - the closest regulatory comparables to K061901.
INOMAX DS (DELIVERY SYSTEM), MODEL 10003
K080484 · Ino Therapeutics · Aug 2008
INOMAX DS
K071516 · Ino Therapeutics, LLC · Oct 2007
INOMAX DS (DELIVERY SYSTEM), MODEL 10003
K070867 · Ino Therapeutics, LLC · Apr 2007
VIANOX DELIVERY SYSTEM, MODEL II
K033779 · Pulmonox Medical, Inc. · Jan 2004
AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002
K000653 · Pulmonox Medical Corp. · Aug 2000
DATEX-OHMEDA INOVENT DELIVERY SYSTEM
K000186 · Datex-Ohmeda · Feb 2000