Cleared Traditional

K212409 - Ulspira TS Nitric Oxide Therapy System (FDA 510(k) Clearance)

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

K212409 · Airgas Therapeutics · Anesthesiology device
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Jun 2023
Decision
696d
Days
Class 2
Risk

K212409 is an FDA 510(k) clearance for the Ulspira TS Nitric Oxide Therapy System. Classified as Apparatus, Nitric Oxide Delivery (product code MRN), Class II - Special Controls.

Submitted by Airgas Therapeutics (Houston, US). The FDA issued a Cleared decision on June 30, 2023 after a review of 696 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Airgas Therapeutics devices

Submission Details

510(k) Number K212409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2021
Decision Date June 30, 2023
Days to Decision 696 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
557d slower than avg
Panel avg: 139d · This submission: 696d
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 K212409.
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