Cleared Traditional

K161237 - HyperView Hyperspectral Tissue Oxygenation Measurement System

K161237 is an FDA 510(k) clearance for HyperView Hyperspectral Tissue Oxygenat..., manufactured by Hypermed Imaging, Inc.. The device is a Class 2 Cardiovascular device with product code MUD cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K161237 · Hypermed Imaging, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
228d
Days
Class 2
Risk

K161237 is an FDA 510(k) clearance for the HyperView Hyperspectral Tissue Oxygenation Measurement System. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Hypermed Imaging, Inc. (Memphis, US). The FDA issued a Cleared decision on December 16, 2016 after a review of 228 days - an extended review 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: 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.

FDA 510(k) Submission Details - K161237

510(k) Number K161237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2016
Decision Date December 16, 2016
Days to Decision 228 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
103d slower than avg
Panel avg: 125d · This submission: 228d
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

Emergo Global Consulting, LLC
Julie Powell

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 73
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K161237.
Masimo O3 Regional Oximeter System
K162603 · Masimo Corporation · May 2017
Kent Camera
K163070 · Kent Imaging, Inc. · May 2017
Ox-Imager CS
K153426 · Modulated Imaging, Inc. · Dec 2016
NIRO-200NX DP
K162117 · Hamamatsu Photonics K.K. · Oct 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