Cleared Abbreviated

K993979 - MARSPO2

K993979 is an FDA 510(k) clearance for MARSPO2, manufactured by Novametrix Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K993979 · Novametrix Medical Systems, Inc. · Anesthesiology device
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Feb 2000
Decision
90d
Days
Class 2
Risk

K993979 is an FDA 510(k) clearance for the MARSPO2, MODEL 2001. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Novametrix Medical Systems, Inc. (Wallingford, US). The FDA issued a Cleared decision on February 22, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Novametrix Medical Systems, Inc. devices

FDA 510(k) Submission Details - K993979

510(k) Number K993979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1999
Decision Date February 22, 2000
Days to Decision 90 days
Submission Type Abbreviated
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
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

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 K993979.
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
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
K993512 · Datex-Ohmeda, Inc. · Mar 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
N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS
K993637 · Nellcor Puritan Bennett, Inc. · Nov 1999