Cleared Traditional

K021469 - MINOLTA PULSOX-2

K021469 is an FDA 510(k) clearance for MINOLTA PULSOX-2, 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 281-day FDA review.

K021469 · Konica Minolta Sensing, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
281d
Days
Class 2
Risk

K021469 is an FDA 510(k) clearance for the MINOLTA PULSOX-2. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Konica Minolta Sensing, Inc. (Denver, US). The FDA issued a Cleared decision on February 12, 2003 after a review of 281 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.

FDA 510(k) Submission Details - K021469

510(k) Number K021469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2002
Decision Date February 12, 2003
Days to Decision 281 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 140d · This submission: 281d
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 687
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K021469.
MICROCAP PLUS/NPB-75
K024300 · Oridion Medical 1987 , Ltd. · Apr 2003
DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER
K024235 · Dolphin Medical, Inc. · Mar 2003
IM2001 PULSE OXIMETER
K012706 · Imagyn Medical Technologies, Inc. · Mar 2003
VITALSAT SERIES
K011518 · Beta Biomed Services, Inc. · Nov 2002
OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER
K014218 · Dolphin Medical, Inc. · Nov 2002
TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES
K021955 · Datex-Ohmeda, Inc. · Oct 2002