Cleared Traditional

K162117 - NIRO-200NX DP

K162117 is an FDA 510(k) clearance for NIRO-200NX DP, manufactured by Hamamatsu Photonics K.K.. The device is a Class 2 Cardiovascular device with product code MUD cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K162117 · Hamamatsu Photonics K.K. · Cardiovascular device
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Oct 2016
Decision
88d
Days
Class 2
Risk

K162117 is an FDA 510(k) clearance for the NIRO-200NX DP. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Hamamatsu Photonics K.K. (Hamamatsu City, JP). The FDA issued a Cleared decision on October 25, 2016 after a review of 88 days - a notably fast clearance cycle.

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: 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 Hamamatsu Photonics K.K. devices

FDA 510(k) Submission Details - K162117

510(k) Number K162117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2016
Decision Date October 25, 2016
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 Consultant

Hyman, Phelps, & Mcnamara
Allyson B. Mullen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MUD Oximeter, Tissue Saturation

All 72
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K162117.
Kent Camera
K163070 · Kent Imaging, Inc. · May 2017
Ox-Imager CS
K153426 · Modulated Imaging, Inc. · Dec 2016
HyperView Hyperspectral Tissue Oxygenation Measurement System
K161237 · Hypermed Imaging, Inc. · Dec 2016
Masimo O3 Regional Oximeter System
K160526 · Masimo Corporation · Jun 2016
SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)
K151305 · Nonin Medical, Inc. · Aug 2015
NIRO-200NX
K143219 · Hamamatsu Photonics K.K. · Jul 2015