FDA 510(k) clearance · back to tracker

VisuBreath

Affirm Medical Technologies II, LLC cleared K261633 on 2026-07-14, decision: substantially equivalent

K-number

K261633

Sponsor

Affirm Medical Technologies II, LLC

Device

VisuBreath

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-07-14

Product code

CCK

Advisory committee

Anesthesiology

Medical specialty

Anesthesiology

Regulation number

868.1400

Official FDA record

Open K261633on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K261633 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.