Cleared Traditional

K942347 - NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000

K942347 is an FDA 510(k) clearance for NELLCOR SYMPHONY PULSE OXIMETER MODEL N..., manufactured by Nellcor, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K942347 · Nellcor, Inc. · Anesthesiology device
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May 1995
Decision
360d
Days
Class 2
Risk

K942347 is an FDA 510(k) clearance for the NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nellcor, Inc. (Lenexa, US). The FDA issued a Cleared decision on May 12, 1995 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Nellcor, Inc. devices

FDA 510(k) Submission Details - K942347

510(k) Number K942347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1994
Decision Date May 12, 1995
Days to Decision 360 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
220d slower than avg
Panel avg: 140d · This submission: 360d
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 502
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K942347.
NELLCOR SYMPHONY N-3000 PULSE OXIMETER
K952316 · Nellcor, Inc. · Aug 1995
NELLCOR N-20PA PORTABLE PULSE OXIMETER
K952222 · Nellcor, Inc. · Aug 1995
NEWOX2
K945754 · Bci Intl., Inc. · Jul 1995
3301T OXITEMP
K946185 · Bci Intl., Inc. · Mar 1995
HEWLETT-PACKARD M1021A MIX VEN OXY SAT PLUG-IN MODULE
K942842 · Hewlett-Packard GmbH · Feb 1995
FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE
K945464 · Fukuda Denshi USA, Inc. · Feb 1995