Cleared Traditional

K210112 - XChange Device, XChange System (FDA 510(k) Clearance)

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

K210112 · Pneuma Therapeutics, Inc. · Anesthesiology device
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Jan 2023
Decision
741d
Days
Class 2
Risk

K210112 is an FDA 510(k) clearance for the XChange Device, XChange System. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Pneuma Therapeutics, Inc. (Tucson, US). The FDA issued a Cleared decision on January 30, 2023 after a review of 741 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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 Pneuma Therapeutics, Inc. devices

Submission Details

510(k) Number K210112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2021
Decision Date January 30, 2023
Days to Decision 741 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
602d slower than avg
Panel avg: 139d · This submission: 741d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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

Regulatory and Quality Solutions, LLC
Michele McDonald

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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

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