VisuBreath— 510(k) K261633
Substantially EquivalentAffirm Medical Technologies II, LLC
FDA 510(k) clearance K261633 for VisuBreath, Substantially Equivalent on 2026-07-14. Applicant: Affirm Medical Technologies II, LLC. Device class: 2.
Summary
VisuBreath from Affirm Medical Technologies II is filed under CCK, gaseous-phase carbon dioxide gas analyzers. The record doesn't give specs or list components.
Class II, 21 CFR 868.1400. Anesthesiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Affirm Medical Technologies II filed from Piedmont, California. The decision came 57 calendar days after receipt (May 18 to July 14, 2026).
Clearance details
- Applicant
- Affirm Medical Technologies II, LLC
- Product code
- Product code CCK
- Device class
- Class 2
- Regulation
- 21 CFR 868.1400
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Piedmont, CA, US
Recent devices under product code CCK
view all- K251641 — GF-310R Multigas Unit (GF-310R)
- K253030 — Capnostream35 Portable Respiratory Monitor (PM35MN)
- K250148 — Medical Gas Analyzer (AG200)
- K243956 — TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
- K251216 — 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line
Adverse events under product code CCK
product code CCK- Death
- 3
- Malfunction
- 11,428
- Total
- 11,431
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.