FDA 510(k) clearance · back to tracker

LIA-1 Catheter (542-1)

Leadoptik, Inc. cleared K251402 on 2025-12-19, decision: substantially equivalent

K-number

K251402

Sponsor

Leadoptik, Inc.

Device

LIA-1 Catheter (542-1)

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-12-19

Product code

KTI

Advisory committee

Ear, Nose, Throat

Medical specialty

Ear, Nose, Throat

Regulation number

874.4680

Official FDA record

Open K251402on 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.

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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.