Cleared Special

K010463 - DATEX-OHMEDA OXYGEN SATURATION MODULE

K010463 is an FDA 510(k) clearance for DATEX-OHMEDA OXYGEN SATURATION MODULE, manufactured by Datex-Ohmeda, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 27-day FDA review.

K010463 · Datex-Ohmeda, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
27d
Days
Class 2
Risk

K010463 is an FDA 510(k) clearance for the DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Datex-Ohmeda, Inc. (Tewksburt, US). The FDA issued a Cleared decision on March 15, 2001 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device 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.

View all Datex-Ohmeda, Inc. devices

FDA 510(k) Submission Details - K010463

510(k) Number K010463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2001
Decision Date March 15, 2001
Days to Decision 27 days
Submission Type Special
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
113d faster than avg
Panel avg: 140d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K010463.
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
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K010419 · Masimo Corp. · Mar 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K003167 · Masimo Corp. · Nov 2000
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K003244 · Masimo Corp. · Nov 2000