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.
Clearance details
- Applicant
- Affirm Medical Technologies II, LLC
- Product code
- 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.