FDA 510(k) clearance · back to tracker

Optiflow Oxygen Kit (AA484J)

Fisher and Paykel Healthcare Limited cleared K262268 on 2026-08-27, decision: substantially equivalent

K-number

K262268

Sponsor

Fisher and Paykel Healthcare Limited

Device

Optiflow Oxygen Kit (AA484J)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-08-27

Product code

BTT

Advisory committee

Anesthesiology

Medical specialty

Anesthesiology

Regulation number

868.5450

Official FDA record

Open K262268on 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 K262268 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.

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Source

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