Cleared Traditional

K121021 - INOMAX DS (DELIVERY SYSTEM) (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K121021 · Ino Therapeutics · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
173d
Days
Class 2
Risk

K121021 is an FDA 510(k) clearance for the INOMAX DS (DELIVERY SYSTEM). Classified as Apparatus, Nitric Oxide Delivery (product code MRN), Class II - Special Controls.

Submitted by Ino Therapeutics (Madison, US). The FDA issued a Cleared decision on September 24, 2012 after a review of 173 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.

View all Ino Therapeutics devices

Submission Details

510(k) Number K121021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2012
Decision Date September 24, 2012
Days to Decision 173 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
34d slower than avg
Panel avg: 139d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K121021.
ULSPIRA TS™ Nitric Oxide Therapy System
K242374 · Airgas Therapeutics, LLC · Jan 2025
EVOLVE Nitric Oxide Delivery System
K242578 · Mallinckrodt Manufacturing, LLC · Jan 2025
EVOLVE Nitric Oxide Delivery System
K240410 · Malinckrodt Manufacturing, LLC · May 2024
NOxBOXi Nitric Oxide Delivery System
K233251 · Linde Gas & Equipment, Inc. · May 2024
Evolve Nitric Oxide Delivery System
K222930 · Mallinckrodt Manufacturing, LLC · Dec 2023
NOxBOXi Nitric Oxide Delivery System
K231823 · Linde Gas & Equipment, Inc. · Aug 2023