510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211561Substantially Equivalent

INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)

Medtronic, Inc., Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211561 is the FDA 510(k) clearance record for INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor), a class II device, cleared for Covidien, LLC on under FDA product code MUD (Oximeter, Tissue Saturation). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show one recall naming K211561.

Clearance record

Decision date
Received
(199 days to decision)
Product code
MUD Oximeter, Tissue Saturation
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Covidien, LLC 6135 Gunbarrel Ave., Boulder CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MUD

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