Cleared Traditional

K182868 - INVOS PM7100 Patient Monitor

K182868 is the FDA 510(k) clearance for INVOS PM7100 Patient Monitor by Covidien, LLC. It is a Class 2 General & Plastic Surgery device (product code MUD) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K182868 · Covidien, LLC · General & Plastic Surgery device
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Jan 2019
Decision
88d
Days
Class 2
Risk

K182868 is an FDA 510(k) clearance for the INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor. 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 January 8, 2019 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 870.2700 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Covidien, LLC devices

Submission Details

510(k) Number K182868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2018
Decision Date January 08, 2019
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
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 General & Plastic Surgery 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 K182868.
Intra.Ox 2.0 Handheld Tissue Oximeter
K191676 · Vioptix, Inc. · Sep 2019
Masimo O3 Regional Oximeter System
K182429 · Masimo Corporation · Jun 2019
SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
K190560 · Nonin Medical, Inc. · May 2019
Presygen/si-1
K171245 · Christie Medical Holdings, Inc. · Aug 2018
Clarifi Imaging System
K181623 · Modulated Imaging, Inc. · Jul 2018
FORE-SIGHT ELITE Module Tissue Oximeter
K180003 · Cas Medical Systems, Inc. · May 2018