Cleared Traditional

K190560 - SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface

K190560 is an FDA 510(k) clearance for SenSmart Model 8006CA Reusable Regional..., manufactured by Nonin Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code MUD cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K190560 · Nonin Medical, Inc. · General & Plastic Surgery device
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May 2019
Decision
58d
Days
Class 2
Risk

K190560 is an FDA 510(k) clearance for the SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006P.... Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on May 2, 2019 after a review of 58 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 Nonin Medical, Inc. devices

FDA 510(k) Submission Details - K190560

510(k) Number K190560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2019
Decision Date May 02, 2019
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUD Device Classification - Class 2, Special Controls

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 71
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K190560.
T-Stat 2.0 Microvascular Tissue Oximeter
K192322 · Spectros Corporation · Sep 2019
Intra.Ox 2.0 Handheld Tissue Oximeter
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Masimo O3 Regional Oximeter System
K182429 · Masimo Corporation · Jun 2019
INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
K182868 · Covidien, LLC · Jan 2019
Presygen/si-1
K171245 · Christie Medical Holdings, Inc. · Aug 2018
Clarifi Imaging System
K181623 · Modulated Imaging, Inc. · Jul 2018