VisuBreath

FDA 510(k) K261633 · Affirm Medical Technologies II, LLC

Substantially Equivalent

510(k) numberK261633

Submission

Device name
VisuBreath
Applicant
Affirm Medical Technologies II, LLC
Piedmont, CA, US
Received
May 18, 2026
Decision date
July 14, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1400
Specialty
Anesthesiology

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Questions and answers

When was VisuBreath cleared by the FDA?

VisuBreath (K261633) received a 510(k) decision of Substantially Equivalent on July 14, 2026, 57 days after the submission was received.

What is the product code of K261633?

The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.