Cleared Traditional

K010413 - MINOLTA PULSOX-3SI

K010413 is an FDA 510(k) clearance for MINOLTA PULSOX-3SI, manufactured by Konica Minolta Sensing, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K010413 · Konica Minolta Sensing, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Aug 2001
Decision
171d
Days
Class 2
Risk

K010413 is an FDA 510(k) clearance for the MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Konica Minolta Sensing, Inc. (Bailey, US). The FDA issued a Cleared decision on August 2, 2001 after a review of 171 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Konica Minolta Sensing, Inc. devices

FDA 510(k) Submission Details - K010413

510(k) Number K010413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2001
Decision Date August 02, 2001
Days to Decision 171 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 140d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 478
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K010413.
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K013792 · Masimo Corp. · Dec 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES
K012992 · Masimo Corp. · Oct 2001
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
K011320 · Hitachi Medical Systems America, Inc. · Aug 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K011851 · Masimo Corp. · Jul 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE
K011670 · Datex-Ohmeda · Jun 2001
NOVAMETRIX MARQUETTE COMPATIBLE SENSORS
K010451 · Novametrix Medical Systems, Inc. · Apr 2001