Cleared Traditional

K102715 - REGIONAL OXIMETER

K102715 is an FDA 510(k) clearance for REGIONAL OXIMETER, 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 88-day FDA review.

K102715 · Nonin Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
88d
Days
Class 2
Risk

K102715 is an FDA 510(k) clearance for the REGIONAL OXIMETER. 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 December 17, 2010 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 Nonin Medical, Inc. devices

FDA 510(k) Submission Details - K102715

510(k) Number K102715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2010
Decision Date December 17, 2010
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 Peers - MUD Oximeter, Tissue Saturation

All 38
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K102715.
MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
K113215 · Nonin Medical, Inc. · May 2012
FORE-SIGHT ABSOLUTE TISSUE OXIMETER
K112820 · Cas Medical Systems, Inc. · Jan 2012
FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030
K094030 · Cas Medical Systems, Inc. · Dec 2010
FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)
K091452 · Cas Medical Systems, Inc. · Aug 2009
REGIONAL OXIMETER SYSTEM, MODEL 7600
K090807 · Nonin Medical, Inc. · Jun 2009
FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040
K061960 · Cas Medical Systems, Inc. · Sep 2006