Cleared Special

K993512 - DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER

K993512 is an FDA 510(k) clearance for DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER, 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 165-day FDA review.

K993512 · Datex-Ohmeda, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
165d
Days
Class 2
Risk

K993512 is an FDA 510(k) clearance for the DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Datex-Ohmeda, Inc. (Louisville, US). The FDA issued a Cleared decision on March 31, 2000 after a review of 165 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. 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. Standard predicate reliance. 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 - K993512

510(k) Number K993512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1999
Decision Date March 31, 2000
Days to Decision 165 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
25d slower than avg
Panel avg: 140d · This submission: 165d
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 K993512.
MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500
K001085 · Nonin Medical, Inc. · May 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA
K000126 · Masimo Corp. · Apr 2000
MODIFICATION TO MARSPO2, MODEL 2001
K000794 · Novametrix Medical Systems, Inc. · Apr 2000
MARSPO2, MODEL 2001
K993979 · Novametrix Medical Systems, Inc. · Feb 2000
NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES
K992455 · Nihon Kohden America, Inc. · Jan 2000
SPACELABS MEDICAL DISPOSABLE SP02 SENSOR
K981655 · Spacelabs Medical, Inc. · Dec 1999