FDA 510(k) clearance · back to tracker

TurbAlign

Spirair, Inc. cleared K243655 on 2025-07-11, decision: substantially equivalent

K-number

K243655

Sponsor

Spirair, Inc.

Device

TurbAlign

Class

Class I

Decision

Substantially Equivalent

Decision date

2025-07-11

Product code

LYA

Advisory committee

Ear, Nose, Throat

Medical specialty

Ear, Nose, Throat

Regulation number

874.4780

Official FDA record

Open K243655on 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 K243655 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.