Cleared Traditional

K261633 - VisuBreath

K261633 is an FDA 510(k) clearance for VisuBreath, manufactured by Affirm Medical Technologies II, LLC. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K261633 · Affirm Medical Technologies II, LLC · Anesthesiology device
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Jul 2026
Decision
57d
Days
Class 2
Risk

K261633 is an FDA 510(k) clearance for the VisuBreath. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Affirm Medical Technologies II, LLC (Piedmont, US). The FDA issued a Cleared decision on July 14, 2026 after a review of 57 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Affirm Medical Technologies II, LLC devices

FDA 510(k) Submission Details - K261633

510(k) Number K261633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2026
Decision Date July 14, 2026
Days to Decision 57 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
83d faster than avg
Panel avg: 140d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCK Device Classification - Class 2, Special Controls

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

All 153
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