Cleared Traditional

K061848 - HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1

K061848 is an FDA 510(k) clearance for HYPERSPECTRAL TISSUE OXYGENATION MEASUR..., manufactured by Hypermed, Inc.. The device is a Class 2 Cardiovascular device with product code MUD cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K061848 · Hypermed, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
131d
Days
Class 2
Risk

K061848 is an FDA 510(k) clearance for the HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1. 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 November 8, 2006 after a review of 131 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.

FDA 510(k) Submission Details - K061848

510(k) Number K061848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2006
Decision Date November 08, 2006
Days to Decision 131 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
6d slower than avg
Panel avg: 125d · This submission: 131d
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 73
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K061848.
INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C
K080769 · Somanetics Corp. · May 2008
PACIFICA
K073407 · Or-Nim Medical , Ltd. · Feb 2008
OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM
K073656 · Hypermed, Inc. · Jan 2008
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
INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325
K053618 · Hutchinson Technology, Inc. · Feb 2006
K061848 · HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1
Download PDF FDA Summary Hypermed, Inc.