Cleared Traditional

K222930 - Evolve Nitric Oxide Delivery System (FDA 510(k) Clearance)

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

K222930 · Mallinckrodt Manufacturing, LLC · Anesthesiology device
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Dec 2023
Decision
436d
Days
Class 2
Risk

K222930 is an FDA 510(k) clearance for the Evolve Nitric Oxide Delivery System. Classified as Apparatus, Nitric Oxide Delivery (product code MRN), Class II - Special Controls.

Submitted by Mallinckrodt Manufacturing, LLC (Madison, US). The FDA issued a Cleared decision on December 6, 2023 after a review of 436 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 Mallinckrodt Manufacturing, LLC devices

Submission Details

510(k) Number K222930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2022
Decision Date December 06, 2023
Days to Decision 436 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
297d slower than avg
Panel avg: 139d · This submission: 436d
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 Consultant

Mallinckrodt Hospital Products, Inc.
David Trueblood

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K222930.
ULSPIRA TS™ Nitric Oxide Therapy System
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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
NOxBOXi Nitric Oxide Delivery System
K231823 · Linde Gas & Equipment, Inc. · Aug 2023
Ulspira TS Nitric Oxide Therapy System
K212409 · Airgas Therapeutics · Jun 2023