FDA 510(k) clearance · back to tracker

SedLine Sedation Monitor

Masimo Corporation cleared K260880 on 2026-07-10, decision: substantially equivalent

K-number

K260880

Sponsor

Masimo Corporation

Device

SedLine Sedation Monitor

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-07-10

Product code

OLW

Advisory committee

Neurology

Medical specialty

Neurology

Regulation number

882.1400

Official FDA record

Open K260880on 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 K260880 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.