510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K071047Substantially Equivalent

Masimo Patient Safety Net

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

K071047 is the FDA 510(k) clearance record for MASIMO PATIENT SAFETY NET, a class II device, cleared for Masimo Corporation on under FDA product code MSX (System, Network And Communication, Physiological Monitors). FDA records list 115 510(k) clearances for Masimo Corporation, from to . As of , FDA records show no recalls naming K071047.

Clearance record

Decision date
Received
(56 days to decision)
Product code
MSX System, Network And Communication, Physiological Monitors
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Masimo Corporation 40 Parker, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MSX

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