510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260880Substantially Equivalent

SedLine Sedation Monitor

Masimo Corporation, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260880 is the FDA 510(k) clearance record for SedLine Sedation Monitor, a class II device, cleared for Masimo Corporation on under FDA product code OLW (Index-Generating Electroencephalograph Software). FDA's definition for product code OLW reads: "Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user". FDA records list 115 510(k) clearances for Masimo Corporation, from to . As of , FDA records show no recalls naming K260880.

Clearance record

Decision date
Received
(115 days to decision)
Product code
OLW Index-Generating Electroencephalograph Software
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Masimo Corporation 52 Discovery, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLW

Trailing 12 months
2 clearances under product code OLW in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OLW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260