Cleared Traditional

K151305 - SenSmart Model 8203CA Regional Oximetry...

K151305 is an FDA 510(k) clearance for SenSmart Model 8203CA Regional Oximetry..., manufactured by Nonin Medical, Inc.. The device is a Class 2 Cardiovascular device with product code MUD cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K151305 · Nonin Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
101d
Days
Class 2
Risk

K151305 is an FDA 510(k) clearance for the SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenS.... 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 August 27, 2015 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2700 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Nonin Medical, Inc. devices

FDA 510(k) Submission Details - K151305

510(k) Number K151305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2015
Decision Date August 27, 2015
Days to Decision 101 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 125d · This submission: 101d
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - MUD Oximeter, Tissue Saturation

All 38
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K151305.
FORE-SIGHT ELITE Module Tissue Oximeter
K180003 · Cas Medical Systems, Inc. · May 2018
Masimo O3 Regional Oximeter System
K162603 · Masimo Corporation · May 2017
Masimo O3 Regional Oximeter System
K160526 · Masimo Corporation · Jun 2016
FORE-SIGHT Elite Absolute Tissue Oximeter
K143675 · Cas Medical Systems, Inc. · Apr 2015
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
K133879 · Cas Medical Systems, Inc. · Apr 2014
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
K123700 · Cas Medical Systems, Inc. · Apr 2013