Cleared Special

K073656 - OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM

K073656 is an FDA 510(k) clearance for OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATI..., manufactured by Hypermed, Inc.. The device is a Class 2 Cardiovascular device with product code MUD cleared through the Special 510(k) pathway after a 30-day FDA review.

K073656 · Hypermed, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
30d
Days
Class 2
Risk

K073656 is an FDA 510(k) clearance for the OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Hypermed, Inc. (Winchester, US). The FDA issued a Cleared decision on January 25, 2008 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K073656

510(k) Number K073656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2007
Decision Date January 25, 2008
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 73
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K073656.
T-STAT 303 ISCHEMIA MONITORING SYSTEM
K081233 · Spectros Corporation · Jul 2008
INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C
K080769 · Somanetics Corp. · May 2008
PACIFICA
K073407 · Or-Nim Medical , Ltd. · Feb 2008
HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1
K061848 · Hypermed, Inc. · Nov 2006
FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040
K061960 · Cas Medical Systems, Inc. · Sep 2006
INSPECTRA STO2 TISSUE OXYGENATION MONITOR
K061619 · Hutchinson Technology, Inc. · Jul 2006
K073656 · OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM
Download PDF FDA Summary Hypermed, Inc.