Cleared Traditional

K211561 - INVOS PM7100 Patient Monitor

K211561 is the FDA 510(k) clearance for INVOS PM7100 Patient Monitor by Covidien, LLC. It is a Class 2 Neurology device (product code MUD) cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K211561 · Covidien, LLC · Neurology device
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Dec 2021
Decision
199d
Days
Class 2
Risk

K211561 is an FDA 510(k) clearance for the INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regio.... Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on December 5, 2021 after a review of 199 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.2700 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K211561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2021
Decision Date December 05, 2021
Days to Decision 199 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 148d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MUD Oximeter, Tissue Saturation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - MUD Oximeter, Tissue Saturation

All 31
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K211561.
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K221010 · Vioptix, Inc. · May 2022
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K203490 · Edwards Lifesciences, LLC · Feb 2021
SnapshotNIR
K201976 · Kent Imaging · Nov 2020
Masimo O3 Regional Oximeter System
K201432 · Masimo Corporation · Aug 2020