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FDA 510(k)

VisuBreath

K-Number: K261633 · 2026-07-14

ApplicantAffirm Medical Technologies II, LLC
Decision Date2026-07-14
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VisuBreath is the device name listed in this FDA 510(k) record. The listed applicant is Affirm Medical Technologies II, LLC. It received FDA 510(k) clearance on 2026-07-14 under 510(k) number K261633. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VisuBreath?

VisuBreath is a medical device that received FDA 510(k) clearance on 2026-07-14. The listed applicant is Affirm Medical Technologies II, LLC. The 510(k) number is K261633.

When did VisuBreath receive FDA 510(k) clearance?

VisuBreath received FDA 510(k) clearance on 2026-07-14, under 510(k) number K261633.

Who is the listed applicant for VisuBreath?

The FDA 510(k) record lists Affirm Medical Technologies II, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VisuBreath?

The FDA product code for VisuBreath is CCK.

Related Devices (Code: CCK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, Inc.K240937AIM (N/A)Inventeur, LLCK230915AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen MaskVyaire Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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